Expansile device for use in blood vessels and tracts in the body and tension application device for use therewith and method

ABSTRACT

A device for expansion within a blood vessel having a wall defining a lumen in the body. A first elongate tubular member has proximal and distal extremities and has a longitudinal axis. An expansile member is carried by the distal extremity of the first elongate tubular member is and movable between contracted and expanded positions. The expansile member has a predetermined configuration in the expanded position. A deformable membrane covers the expansile member, and is sized so as to be capable of overlying and underlying the expansile member in the expanded position. A deployment mechanism is carried by the proximal extremity of the first elongate tubular member and is adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded positions. A deployment mechanism includes a push-pull wire with proximal and distal extremities and extends through the first elongate tubular member and is coupled to the expansile member.

This is a continuation-in-part of prior application Ser. No. 08/972,383,filed Nov. 18, 1997 now U.S. Pat. No. 5,922,009 which is acontinuation-in-part of application Ser. No. 08/798,870, filed Feb. 11,1997 which issued as U.S. Pat. No. 5,782,860 on Jul. 21, 1998.

This invention relates to an expansile device and tension applicationdevice for use therewith, for use in vascular and non-vascular tracts inthe human body and method and more particularly for percutaneousocclusion of vascular access sites in the human body.

Percutaneous access to the blood vessels and organs of the human bodyfor diagnosis and treatment of disease processes has heretofore beenaccomplished. Percutaneous vascular procedures are performed involvingthe coronary, peripheral and cerebral vasculature. These proceduresinclude coronary and peripheral angiography, angioplasty, atherectomies,coronary retroperfusion and retroinfusion, cerebral angiograms,treatment of strokes, cerebral aneurysms and the like. Patientsundergoing such procedures are often treated with anti-platelet drugs,anticoagulants such as heparin, thrombolytics, or a combination thereof,all of which interfere with coagulation making it more difficult for thebody to seal a puncture site. Various devices and methods haveheretofore been utilized, however, they all have had deficiencies,including the use of complicated devices and methods. In addition,difficulties are still encountered in obtaining good seals. There istherefore a need for a device and method for percutaneous access andocclusion of vascular access sites and other puncture sites and naturaltracts in the human body which overcome the deficiencies of prior artdevices and methods.

In general, it is an object of the present invention to provide aclosure device and method for percutaneous access and occlusion ofvascular access sites, other puncture sites and natural tracts in thehuman body which will make possible a positive seal of the puncture siteor tract promoting rapid healing of the puncture site or tract.

Another object of the invention is to provide a closure device andmethod of the above character which can be easily and reliably used.

Another object of the invention is to provide a closure device andmethod of the above character in conjunction with which a biologicalsealant is used by introduction into the puncture site or natural tract.

Another object of the invention is to provide a closure device andmethod of the above character which leaves a small enough opening afterremoval of the closure device so that the biological sealant will sealthe remaining opening.

Another object of the invention is to provide a closure device andmethod of the above character which enables continued substantiallyunobstructed blood flow during deployment and use of the closure device.

Another object of the invention is to provide a closure device andmethod of the above character in which no foreign body remains in theblood vessel.

Another object of the invention is to provide a closure device andmethod of the above character that permits early ambulation of patientsand avoids prolonged bed rest.

Another object of the invention is to provide a closure device andmethod of the above character which reduces the risk of bleeding,formation of arteriovenous fistula, formation of pseudoaneurysm,thrombosis with distal embolization and infection.

Another object of the invention is to provide a closure device andmethod of the above character that reduces the risk of causing ischemiaof an extremity.

Another object of the invention is to provide a closure device andmethod of the above character that is inexpensive, quick, safe, easy touse and is disposable.

Another object of the invention is to provide an expansile device andmethod of the above character in which the configuration of an expansileassembly is determined by countervailing mechanical forces of anexpansile member and a membrane.

Another object of the invention is to provide an expansile device andmethod of the above character in which tensioning means is provided forreversibly maintaining engagement of the expansile assembly against thevessel wall of a puncture and to free the operator's hands from havingto hold the device after it is correctly deployed in the puncture.

Another object of the invention is to provide an expansile device andmethod of the above character in which tensioning means is provided forreversibly maintaining engagement of the expansile assembly against thevessel wall of a puncture by applying a substantially constant force oftension over a range of motion.

Another object of the invention is to provide an expansile device andmethod of the above character in which the expansile member is capableof being expanded to different sizes and configurations.

Another object of the invention is to provide an expansile device andmethod of the above character with which the operator is capable ofconfirming the size to which the expansile member is expanded.

Another object of the invention is to provide an expansile device andmethod of the above character in which tensioning means is provided forreversibly maintaining engagement of the expansile assembly against thevessel wall of a puncture by applying a varying force of tension over arange of motion.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments and the methodsusing the same are described in conjunction with the accompanyingdrawings.

FIG. 1 is a side-elevational view partially in section of a closuredevice for obtaining percutaneous access and occlusion of puncture sitesin the human body incorporating the present invention and having closuremeans in a de-deployed or retracted position.

FIG. 2 is a cross-sectional view taken along the line 2--2 of FIG. 1.

FIG. 3 is a side-elevational isometric view of the distal end of thedevice shown in FIG. 1 with the closure means in a deployed or extendedposition.

FIG. 4 is a cross-sectional view taken along the line 4--4 of FIG. 3 andshows the manner in which a seal is formed with respect to a puncture.

FIGS. 5A-5D are cartoons demonstrating the method of using the device ofthe present invention for occluding a vascular access or puncture site.

FIG. 6 is a partial isometric view of an alternative closure assemblyfor the closure device shown in FIG. 1.

FIG. 7 is a side-elevational view partially in section of anotherembodiment of the closure device incorporating the present invention.

FIG. 8 is a cross-sectional view taken along the line 8--8 of FIG. 7.

FIG. 9 is a cross-sectional view taken along the line 9--9 of FIG. 8.

FIG. 10 is a side-elevational isometric view of the distal end of thedevice of FIG. 8 with the closure assembly in a deployed or expandedposition.

FIG. 11 is a side-elevational view partially in section of anotherembodiment of the closure device incorporating the present invention.

FIG. 12 is a cross-sectional view taken along the line 12--12 of FIG.11.

FIG. 13 is a partial side-elevational view of the distal extremity ofthe closure device of FIG. 11 with the closure mechanism in a deployedposition.

FIG. 14 is a view looking along the line 14--14 of FIG. 13.

FIG. 15A is a side-elevational view partially in section of the proximalend of another embodiment of the closure device incorporating thepresent invention.

FIG. 15B is a side-elevational view partially in section of the distalend of the embodiment shown in FIG. 15A.

FIG. 16 is a side-elevational view partially in section of the distalend of the device of FIG. 15 with the closure assembly in a deployedposition.

FIG. 17 is a view partially in section taken along the line 17--17 ofFIG. 16.

FIG. 18 is a side-elevational view partially in section of anotherembodiment of the closure or expansile device incorporating the presentinvention.

FIG. 19 is a side-elevational view partially in section of the distalend of the device of FIG. 18 with the expansile assembly in an free orexpanded position without the covering membrane.

FIG. 20 is an plan view of the top of the tensioning device of thepresent invention taken along the line 20--20 of FIG. 23.

FIG. 21 is a cross-sectional view taken along the line 21--21 of FIG.23.

FIG. 22 is a side-elevational view partially in section of thetensioning device of the present invention in the open position.

FIG. 23 is side-elevational view partially in section of the tensioningdevice of the present invention in the closed, neutral position.

FIG. 24 is a cross-sectional view of the device of FIG. 18 with oneembodiment of the biological sealant introducing means.

FIG. 25 is an side-elevational view partially in section of anotherembodiment of the expansile device of the present invention shown withits biological sealant introducing means.

FIG. 26 is a cross-sectional view taken along the line 26--26 of FIG.25.

FIG. 27 is an isometric view of the device in FIG. 18 with anotherembodiment of the biological sealant introducing means.

FIG. 28 is an isometric view the third elongate member that obturatesthe second lumen in the biological sealant introducing means of FIG. 27.

FIG. 29 is a cross section view taken along the line 29--29 of FIG. 27.

FIG. 30 is a cross-sectional view of another embodiment of the thirdelongate tubular member which is part of the biological sealantintroducing means of FIG. 27.

FIG. 31 is an isometric view of the device in FIG. 18 with anotherembodiment of the biological sealant introducing means.

FIG. 32 is a cross-section view taken along the line 32--32 of FIG. 30.

FIG. 33 is an isometric view of another embodiment of the tensioningdevice of the present invention in the open position.

FIG. 34 is a side elevational view partially in section of anotherembodiment of the closure device incorporating the present invention inthe contracted position.

FIG. 35 is a sectional view taken along the line 35--35 of FIG. 34.

FIG. 36 is a side elevational view partially in section of the distalextremity, including the expansile member, of the device in FIG. 34shown in the expanded position.

In general, the closure device of the present invention is used for thepercutaneous occlusion of a puncture site and natural tract in the humanbody. The human body has an outer layer of skin and inner layers oftissue surrounding a blood vessel having a lumen therein defined by avessel wall. A puncture site traverses these layers and, in the case ofa vascular access puncture, the vessel wall. The closure devicecomprises a flexible elongate tubular member having proximal and distalextremities, an outer diameter and extending along a longitudinal axis.The flexible elongate tubular member has a first lumen extendingtherethrough from the proximal extremity to the distal extremity. Aclosure assembly is carried by the distal extremity and includes aclosure mechanism and an impermeable membrane at least partiallycovering the closure mechanism. Deployment means carried by the proximalextremity of the flexible elongate tubular member are adapted to beoperated by the human hand. The deployment means extends through theflexible elongate tubular member, includes a push-pull wire and iscoupled to the closure assembly for moving the closure assembly from ade-deployed or contracted position for introduction into and through apuncture to a deployed position for forming a seal occluding thepuncture.

More specifically, as shown in FIGS. 1-4, the closure device 21 of thepresent invention for percutaneous occlusion of puncture sites andnatural tracts consists of a flexible elongate tubular member 22 formedof a suitable plastic material such as polyethylene or polyurethane orpolyimide. The flexible elongate tubular member 22 has a longitudinalaxis and proximal and distal extremities 23 and 24. The flexibleelongate tubular member 22 is provided with a main circular incross-section first lumen 26 which may be centrally disposed extendingfrom the proximal extremity 23 to the distal extremity 24. It is alsoprovided with an additional or second lumen 27 which may becrescent-shaped as shown in cross-section in FIG. 2 extending from theproximal extremity 23 to the distal extremity 24 where it opens throughan external port 28. A plug 29 of a suitable material such as plastic isplaced in the lumen 27 to occlude the lumen 27 distal of the port 28.

The flexible elongate tubular member 22 is of a suitable size, as forexample a diameter ranging from 1-9 French corresponding to an outsidediameter ranging from approximately 0.3 to 3.0 millimeters. The flexibleelongate tubular member has a suitable length as for example 15-30centimeters with the external port 28 being disposed a suitable distanceadjacent to and proximal of the closure assembly 32, as for example from1-10 millimeters up to several centimeters. The first lumen 26 may havean inside diameter ranging from 0.015" to 0.080", preferably0.020"-0.030" while the second lumen 27, if crescent-shaped may have along axis dimension of approximately 0.015" to 0.080".

Closure means in the form of a closure assembly 32 is carried by thedistal extremity 24 of the flexible elongate tubular member 22 and iscoupled or secured to deployment means or mechanism 33 for movement froma contracted, retracted or de-deployed position to an expanded ordeployed position. The closure assembly 32 includes a closure mechanism34 and an impervious membrane 36 which covers the closure mechanism 34.The closure mechanism 34 as shown in FIGS. 3 and 4 is in the form of acomplex geometrical configuration, as for example a coil, when in a freestate. The coil 34 is formed of a suitable material which can beelongated without permanent deformation but when freed or unconstrainedhas a substantial portion thereof which will return to a generallyplanar or disk-like configuration to which it has been annealed. Onematerial found to be particularly suitable for such an application is asuper-elastic or shape memory element as formed of a nickel/titaniumalloy, often called Nitinol. The coil 34 has a plurality of generallycircular turns 37 and has first and second ends 38 and 39 secured to thedeployment mechanism 33 in a manner hereinafter described. The turns 37of the coil 34 lie in a single plane which is generally perpendicular tothe longitudinal axis of the flexible elongate tubular member 22.

The coil 34 has a diameter which is selected to overlap a puncture siteas hereinafter described to occlude the puncture site. Typically, asuitable diameter such as 3 to 7 millimeters and preferablyapproximately 5 millimeters is used. In the de-deployed configurationthe constrained coil 34 has a suitable diameter ranging from 0.1 mm to3.0 mm. The coil 34 can be formed of wire having a diameter ranging from0.002" to 0.004" (0.05 to 0.1 millimeters) and preferably about 0.003"(0.076 millimeters). Alternatively, it can be formed of ribbon generallyrectangular in cross-section and can have a thickness of approximately0.001" to 0.002" (0.025 to 0.05 mm.) and a width of approximately 0.003"to 0.005" (0.076 to 0.13 millimeters).

The deployment means or mechanism 33 consists of a push-pull wire 41which is slidably disposed in and extending through the first or mainlumen 26 and has proximal and distal extremities 42 and 43. Thepush-pull wire 41 is formed of a suitable material such as stainlesssteel and has a suitable diameter as for example 0.005" to 0.032". Meansis provided for securing the two ends 38 and 39 of the coil 34 to thedistal extremity 43 of the push-pull wire 41 and consists of solderforming joints or adhesively bonded joints. As shown in FIG. 1 theproximal end 42 of the push-pull wire 41 extends out of the proximalextremity 23 of the flexible elongate tubular member 22 and isoperatively connected to a handle assembly 44 as hereinafter described.

The handle assembly 44 is formed of a body 46 of suitable material suchas plastic and is mounted on the proximal extremity 23 of the flexibleelongate tubular member 22. The handle 44 is sized so it is adapted tobe grasped by the human hand and is provided with means for operation ofthe push-pull wire 41 which includes a button 47 adapted to be engagedby a finger of the hand holding the handle. The button 47 is mounted ona protrusion 48 which is slidably mounted in a longitudinally extendingslot 49 in the handle 44 and is movable between first and secondpositions for deploying the coil 34 from a retracted or contractedelongate position constrained within the flexible elongate tubularmember 22 to an expanded position outside of the tubular member 22. Theproximal extremity 42 of the push-pull wire 41 is secured to theprotrusion 48 in a suitable manner such as a wire clamp or adhesive (notshown). The slot 49 opens into sideways extending notches 51 and 52provided in the body which can receive the protrusion 48 in either thefirst or second position to retain the push-pull wire 41 in the desiredposition as hereinafter described.

The closure means 32 also includes a flexible impermeable membrane 36which is carried by and secured to the distal extremity 24 of theflexible elongate tubular member 22. It is desired that this membrane 36be very flexible and it therefore has a wall thickness ranging from0.0005" to 0.010" (0.0127 to 0.076 millimeters) and preferably 0.001"(0.025 millimeters). It can be formed of any suitable flexibleimpermeable material such as elastomeric and non-elastomeric materials.For example, latex or silicone have been found to be suitable. Themembrane 36 should be substantially impermeable to blood and otherliquids. It is preferably formed as a tubular sock which can have anelongate generally cylindrical configuration with one closed end 54 andthe other end circumscribed by an opening 56 which is defined by a rim57 of the impermeable membrane. This rim 57 is circumferentially securedto the distal extremity 24 in a suitable manner such as by an adhesive(not shown) and preferably interiorly within the first or main lumen 26.However, if desired, the rim 57 can also be affixed exteriorly to theouter surface of the tip 31 of the distal extremity 24 of the flexibleelongate tubular member 22. The impermeable membrane 36 is formed insuch a manner so that it can, upon manufacture of the device 21, bedisposed internally of the distal extremity 24 of the flexible elongatetubular member 22 and be folded inwardly with folds 58 in the main lumen26 to accommodate closure mechanism 34 in a constrained, retracted orcontracted or de-deployed position as shown in FIG. 1. It also has theflexibility of being moved outwardly by operation of the push-pull wire41 to the sock-like dotted line position 61 shown in FIG. 1.

The impermeable membrane 36 also can be caused to assume a disk-likeplanar configuration as shown by the dotted-line position 62 in FIG. 1.This is accomplished by operation of the deployment mechanism 33 to movethe push-pull wire 41 distally to urge the closure mechanism 34 distallyto move out of the lumen 26 into the dotted-line position 61. As soon asthe closure mechanism 34 is clear of the main lumen 26, it will expandinto its memorized configuration. As this expansion is occurring, themembrane 36 covering the coil 34 is caused to move from the sock-likeconfiguration 61 to the disk-like circular configuration 62 so that themembrane 36 is disposed on opposite sides of the closure mechanism 34and lies in generally parallel planes which are generally perpendicularto the longitudinal axis of the flexible elongate tubular member 22 forpercutaneously occluding a puncture as hereinafter described. Thedeployed closure mechanism 34 is sufficiently rigid so as to provide asupporting framework for the membrane 36.

The closure device 21 also consists of biological sealant introducermeans 81 carried by the handle 44 and the flexible elongate tubularmember 22 for introducing a biological sealant into a puncture proximalof the closure assembly 32 after the closure assembly 32 has beenpositioned. The biological sealant is of a suitable type such as atwo-component fibrin glue, thrombin, fibrin, collagen-thrombin,collagen, Avitene (trademark), Gelfoam (trademark), cellulose, gelatin,and mixtures or slurries thereof. It should be appreciated that otherbiological sealants or pharmacological agents may also be introducedinto a puncture utilizing this device.

The biological sealant introducer means 81 can consist of a fitting of asuitable type such as a wye adapter 82 which is provided with first andsecond arms 83 and 84 with first and second syringes 86 and 87 removablymounted thereon on and containing the two separate constituents offibrin glue being used as the biological sealant. The fitting 82 isconnected to a flexible tubular member 91 which is sealed into thehandle 44 and is provided with a lumen 92 therein in communication withthe lumen (not shown) of the arms 83 and 84. The distal end of the flowpassage 92 in the tubular member 91 is aligned to be in communicationwith the second lumen 27 of the flexible elongate tubular member 22 sothat when the syringes 86 and 87 are operated the biological sealantcomponents are mixed and pass through the flow passage 92 existing viathe external port 28 of the second lumen 27.

Operation and use of the device 21 in performing the method of thepresent invention in the percutaneous access and occlusion of vascularaccess sites and other puncture sites in the human body may now bedescribed in conjunction with the cartoons shown in FIGS. 5A-5D. Let itbe assumed that a percutaneous femoral arterial catheterization is to beperformed. After sterile preparation, a thin-walled hollow needle withsyringe (not shown) is percutaneously inserted through the skin 101, theunderlying subcutaneous tissue 102 and then through the wall 103defining the lumen 104 of a vessel 107 such as the femoral artery toform a puncture 106. Intra-arterial access is confirmed by theaspiration of arterial blood. A flexible wire (not shown) is then passedthrough the needle into the artery 107 and the needle is removed,leaving only the wire in place in the puncture 106. A vessel dilator(not shown) with a shorter conventional over-lying sheath 111 is passedover the wire through the puncture 106 into the lumen 104 after whichthe wire and dilator are removed. The sheath 111 extends from outsidethe patient through skin 101 and subcutaneous tissues 102 and throughthe wall 103 into the lumen 104 as shown in FIG. 5A. Various diagnosticand therapeutic catheters and other similar medical devices can bepassed through the sheath 111, whose diameter can range from 3 to 24French, to perform desired procedures, as for example an angioplastyprocedure during which time anti-coagulants such as heparin have beenintroduced. At the conclusion of any such procedure, such instrumentsare removed leaving only the sheath 111 in place.

Let it be assumed that it is now desired to seal the puncture 106. Theclosure device 21 of the present invention with the closure assembly 32in the retracted position as shown in FIG. 1 is inserted into the sheath111 while maintaining standard sterile precautions. The distal extremity24 of the flexible elongate tubular member 22 is passed through thesheath 111 and into the lumen 104 so that it extends a short distance upto several inches beyond the distal extremity of the sheath 111 as shownin FIG. 5A. The sheath 111 is then slowly, incrementally withdrawnproximally while maintaining the device 21 as stationary as possible. Ascan be seen from FIG. 5B, the flexible elongate tubular member 22 has alength so that the sheath can be removed from the puncture 106 whileretaining the distal extremity 24 in the lumen 104 and without removingthe handle 44. When the sheath 111 has been withdrawn as shown in FIG.5B, the closure assembly 32 may be deployed by operation of thedeployment mechanism 33. Alternatively, the distal extremity 24 of theflexible elongate tubular member 22 can be passed into the lumen 104 aslightly greater distance, the device 21 deployed with the sheath 111still in position, and then both the sheath 111 and device 21 slowlywithdrawn so that the sheath 111 is removed from the lumen 104 with thedeployed device 21 appropriately positioned in the lumen 104.

Before deployment of the closure assembly 32, the finger button 47 is inits most proximal-most position with the protrusion 48 being seated inthe notch 51 as shown in FIG. 5A. Now let it be assumed that it isdesired to move the closure assembly 32 from a contracted or retractedposition where it is disposed within the first main lumen 26. When it isdesired to move the closure assembly 32 to an expanded or open position,the button 47 is retracted from the notch 51 and slidably advanced alongthe slot 49 to push the distal extremity 43 of the push-pull wire 41distally to cause the Nitinol closure mechanism 34 to be advanceddistally and to carry the folded impermeable membrane 36 out of thefirst or main lumen 26 to cause it to assume a sock-like shape as shownin position 61 in FIG. 1. Continued forward movement of the fingerbutton 47 causes further longitudinal movement of the push-pull wire 41which causes further distal movement of the closure mechanism 33 untilit clears the first lumen 26 so that it is substantially free to causeit to expand into its super-elastic or shape memory form of a coil tocarry with it the flexible impervious membrane 36 to assume thedisk-like configuration represented by position 62 as shown in FIGS. 1and 4. The finger knob is then positioned so that the protrusion 48 isseated in the notch 52.

After the closure mechanism has been fully deployed, the handle 44 canbe utilized to gradually retract the flexible elongate member 22 toensure that the proximal surface of the flattened flexible membrane 36is brought into close engagement with the inner surface of the wall 103forming the lumen 104 in which the closure assembly 32 is disposed. Thisforms a liquid tight seal between the closure assembly 32 and the wall103 immediately adjacent the puncture 106 which in turn enables accurateand effective deposition of the biological sealant into the puncture 106as hereinafter described. Such a liquid tight seal is also necessary inconnection with the present invention to prevent the leakage of bloodthrough the puncture 106. This serves to prevent blood from interferingwith attempts to safely and permanently occlude and seal the puncture106 and to prevent inadvertent intravascular deposition of sealant.

The formation of a good seal between the occlusion assembly 32 and thewall 103 of the vessel 107 can be ascertained in several ways. By way ofexample the absence of arterial blood in the puncture 106 serves toverify that a good seal has been made. Attempts to aspirate blood fromthe second lumen 27 with no blood return therefrom also indicatesaccurate placement of the device 21. Alternatively, fluoroscopy can beutilized to check the position of the closure assembly 32. This is madepossible because of the radio opacity of the closure mechanism 34. Radioopaque dyes may also be utilized to ascertain whether the puncture hasbeen effectively sealed. A small amount of radio opaque dye may beinjected into the subcutaneous tissue adjacent the puncture 106. Iffluoroscopy demonstrates intravascular dye then there is inadequateplacement of the closure assembly 32. If perchance there is any leakage,the button 47 can be engaged by the finger and retracted out of thenotch 52 and proximally for a slight distance and then moved distally tore-deploy the mechanical assembly 32, thereafter grasping the handle 44and pulling the flexible elongate member 22 proximally to againreestablish a seal with the wall 103 adjacent the puncture 106.

As soon as it has been established that a good seal has been formed inthe manner hereinbefore described between the closure assembly 32 andthe wall 103 adjacent the puncture 106, a biological sealant to beutilized can be introduced into the puncture 106 to provide a sealant116 which extends throughout the puncture 106 from immediately outsidethe vessel 107 up to as far as the outer surface of the skin 101 asshown in FIG. 5C. It should be appreciated, however, that it may not benecessary to introduce an amount of sealant so great as to cause it toextend proximally to the skin. Assuming that the biological sealant is afibrin glue supplied in two ports in the syringes 86 and 87, thephysician utilizing the closure device 21 while holding the handle 44 inone hand utilizes the other hand to operate the syringes 86 and 87 tocause the constituents of the biological sealant to be introduced intothe wye adapter 82 where they are mixed with each other and introducedthrough the tubular member 91 and into the second lumen 27, thencethrough the exit port 28 which is adjacent the closure assembly 32. Itshould be appreciated that in addition to holding the handle 44 in orderto maintain engagement of the closure assembly 32 with the vessel wall103, any suitable device by way of example a pin-vise may be applied tothe flexible elongate tubular member 22 immediately adjacent the skin101 so that the engagement is maintained and the physician has a freehand. The fibrin glue seals the innermost tissue layers in the puncture106 and then, as hereinbefore described, can backfill the puncture 106through the subcutaneous tissue 102 and to the skin 101, surrounding thedistal extremity 24 of the flexible elongate tubular member 21 as shownin FIG. 5C. If necessary, the completion of this backfilling can beobserved by the fibrin glue exiting from the puncture 106. As soon asthis occurs, the physician terminates further movement of the syringes86 and 87 and then while still holding the handle 44 to retain theclosure assembly 32 in place, permits the fibrin glue to set up or curewithin the puncture 106 for a period of time suitable to permit thefibrin glue to form a sticky adherent clot in the puncture 106 but toprevent the fibrin glue forming a clot which is too firm so as topreclude easy withdrawal of the closure device 21. Typically this rangesfrom a period of time of 30 seconds to 15 minutes and preferably aperiod of time of approximately 1-2 minutes. The aforementionedbiological sealants only adhere to collagen-containing tissues whichprevents them from bonding to the flexible elongate tubular member 22.As soon as the physician determines that the fibrin glue has assumed thedesired state, the button 47 carried by the handle 44 is engaged by thefinger of the physician's hand and moved out of the slot 52 and thenretracted proximally in the slot 49 to cause proximal movement of thepush-pull wire 41 to cause a gradual straightening of the closuremechanism 34 to bring it substantially within the interior of the lumen26 thereby permitting collapse of the flexible membrane 36 so that itcan assume a generally sock-like configuration. Thus as soon as thebutton 47 has been moved to its most proximal position and moved intothe notch 51, the closure device 21 can gently be pulled from the seal116 provided in the puncture 107. The hole (not shown) left in thesealant 116 after withdrawal of the flexible elongate tubular member 22and the membrane 36 carried thereby closes on itself due to thesufficiently gel-like state of the fibrin glue or other agent.Thereafter, the site of the puncture 106 is observed to ascertainwhether or not bleeding is occurring therefrom. An excellent biologicalseal is formed with nothing remaining at the puncture site except forthe biological sealant which within a relatively short period of time asfor example 1-2 weeks will be absorbed by the body.

From the foregoing it can be seen that there has been provided a closuredevice and a method for utilizing the same which makes it possible toquickly and efficaciously close the puncture which has been madenecessary for performing a desired medical procedure as for example anangioplasty procedure. An excellent seal is formed even thoughanticoagulants have been introduced into the blood of the patient duringthe procedure to prevent the formation of clot. The application offibrin glue in this manner permits the formation of a good clot to sealthe puncture without danger of re-bleeding occurring.

It also should be appreciated that during this procedure in performingthe closure of the puncture site, blood can continue to flowsubstantially unimpeded through the lumen 104 of the vessel. This lackof obstruction is made possible because of the small size of the distalextremity of the closure device 21 and also because of the small size ofthe closure assembly 32 carried by the distal extremity 24 of the device21. When the closure assembly 32 is deployed as hereinbefore described,it has a relatively small diameter in comparison to the size of thelumen into which it is introduced. In addition it has a flat planarconfiguration which, when brought into engagement with the inner surfaceof the wall 103, is substantially flush with the inner surface of thewall 103. Even when the closure assembly 32 is being de-deployed itoccupies very little space as it is being withdrawn.

Another embodiment of the closure assembly is shown in FIG. 6 which canbe utilized in place of the closure assembly 32 on the distal extremity24 of the flexible elongate tubular member 22 carried by the handle 44.As shown, the closure assembly 131 consists of a closure mechanism 132which is covered by a flexible impermeable membrane 133. The closuremechanism 132 can be formed of the same super-elastic or shape memorymaterial as the closure mechanism 34 but rather than having a coil-likeconfiguration such as shown in FIG. 1, 3 and 4, it includes a differentcomplex geometrical configuration as for example a flower-likeconfiguration as shown in FIG. 6. Thus it can be formed of a Nitinolribbon or wire of a single length having ends 137 and 138 which aresecured to the distal extremity 43 of the push-pull wire 41 in a mannersimilar to that hereinbefore described. The wire ribbon 136 has beenannealed to have a super-elastic or shape memory form for theflower-like configuration shown in which a plurality of loops 141, asfor example three as shown are provided on the wire ribbon 136. Theloops 141 are oval shaped, approximately equal in size and have curvedouter extremities 142. The loops 141 lie in a single plane and have thelongitudinal axes of the loops spaced apart by equal angles of about120°. It should be appreciated that if desired, additional loops can beprovided with the loops being spaced equally over 360°. Since the loops141 correspond to the shape of petals of a flower, the configurationshown in FIG. 6 can be described as a flower-like arrangement in whichthe loops 141 lie in a common plane which is generally perpendicular tothe longitudinal axis of the flexible elongate member 22.

The membrane 133 which forms a part of the closure assembly 131 can beformed of the same material as the membrane 36 and can be secured in thesame manner to the tubular member 22 so that when the closure mechanism132 is in a retracted position within the lumen 26 it also can beprovided with folds in the same manner as the membrane 36. The closuremechanism 132 can be straightened in a similar manner and brought into aretracted position similar to the closure mechanism 34. The closureassembly 131 also can be deployed in a similar manner. When deployed, itwill cause the impermeable membrane to assume a generally flat planarconfiguration which is still substantially in the form of a circle asdetermined by the outer curved extremities 142 of the loops 141 withvery slight variations from a circle between the outer extremities ofadjacent loops. Thus a good seal can be formed with the wall 103 of thevessel 107 in the same manner as with the closure assembly 32. Thus itcan be seen that the operation and use of the closure assembly of FIG. 6can be very similar to that described for use of the closure assembly 32and with generally the same attendant advantages. It should beappreciated that other arrangements of closure mechanisms can beprovided for causing appropriate deployment of the impervious membraneto form a seal without departing from the scope of the presentinvention. The sizes and shapes of the closure assemblies can beselected to be appropriate for the puncture to be occluded. Thus forexample the flower arrangement shown in FIG. 6 can have the same size asthe coil arrangement shown in FIGS. 1, 3 and 4 or alternatively can bedecreased or increased in size as desired. Furthermore, by altering thenumber of petals or loops, the shape can also be varied from that of acircle to that of substantially a triangle or square.

Another embodiment of a closure device incorporating the presentinvention is shown in FIGS. 7-10. The closure device 151 is showntherein. The closure device is very similar to that shown in FIG. 1 withthe principal difference being in the type of closure assembly utilizedon the distal extremity 24 of the flexible elongate tubular member 22.Thus all of the parts of the closure device 151 carry the same numbersas the closure device 21 shown in FIG. 1 to the distal extremity 24 onwhich the closure assembly 156 is carried. The closure assembly 156consists of a closure mechanism 157 which is covered by a flexibleimpermeable membrane 158. The closure mechanism 157 consists of aplurality of rod-like elements 161, struts or arms of at least three innumber which are circumferentially spaced apart and have proximal ends162 which are embedded in the distal extremity 24 of the flexibleelongate tubular member 22. This can be accomplished in a suitablemanner such as by extruding the plastic forming the tubular member overthe proximal ends 162 or alternatively by placing axially aligned boresin the distal extremity 24 and securing the proximal ends 162 therein bysuitable means such as an adhesive. The exposed portions of the rod-likeelements 161 as shown in FIG. 7 are formed of a suitable material suchas stainless steel or Nitinol and are inclined inwardly in a distaldirection to provide a truncated cone-like shape. The distal ends 163 ofthe rod-like elements 161 can be bonded or fastened together in asuitable manner such as by welding or solder to provide a generallyhemispherical tip 166 which is also secured to the distal extremity 43of the push-pull wire 41. The rod-like elements 161 are provided withweakened regions or notches or memorized bending points 171approximately a substantially equal distance from the proximal anddistal ends 162 and 163 to form hinge points 171. The lengths of theexposed portions of the rod-like elements 161 may be selected tocorrespond to a selected diameter of the closure mechanism 157.

The membrane 158 which covers the closure mechanism 157 has a sock-likeconfiguration with a closed end 176 which overlies the hemispherical tip166 and an a open end which is defined by the circular rim 177 which isbonded to the exterior surface of the distal extremity 24 of theflexible elongate tubular member 22 by an adhesive (not shown).

Operation and use of the closure device 151 may now be briefly describedas follows. It should be appreciated that imposition of the button 47with respect to the notches 51 and 52 is reversed in that the button ispositioned in the notch 52 when the closure assembly 156 is in thede-deployed or unexpanded condition as shown in FIG. 7 rather than inthe notch 51. A closure device 151 can be introduced into the sheath 111in the unexpanded condition shown in FIG. 7 in the manner hereinbeforedescribed with respect to the device 21 and after the closure assembly156 is within the lumen 104 of the vessel 107 the closure assembly 156can be deployed or moved to an expanded position by moving the button 47proximally to cause a pulling force to be applied to the hemisphericaltip 166 to cause a pushing force to be applied to the rod-like elements161 to cause them to be bowed outwardly and to bend or fold about thehinge points 171 and at the same time to carry with them the membrane158. Continued movement of the button 47 proximally until it reaches theslot 51 will cause the rod-like elements 161 to cause the portions 161ato generally overlie the portions 161b and to extend radially from thelongitudinal axis of the flexible elongate tubular member 22 atsubstantially right angles thereto as shown in FIG. 10. The membrane 158covering the same is similarly caused to assume a generally circulardisk-like configuration lying in a single plane which can be broughtagainst the inner surface of the wall 103 of the vessel 107 in the samemanner that the closure assembly 32 hereinbefore described is broughtinto contact with the wall. Thereafter the procedure hereinbeforedescribed can be used for forming the seal with the puncture 106 and topermit introduction of the biological sealant. After this procedure hasbeen completed, the closure mechanism 157 can be de-deployed by movingthe same to an unexpanded condition by moving the knob 47 proximally tocause the push-pull wire 41 to move the hemispherical tip 166 distallyand to carry with it the membrane 158 until the closure assembly 156assumes its original unexpanded or de-deployed generally cylindricalconfiguration which is in alignment with the longitudinal axis of theflexible elongate tubular member 22 as shown in FIG. 7 after which theclosure device 151 can be removed to form the desired occlusion for thepuncture 106. It should be appreciated that by varying the number ofrod-like elements the shape of this closure assembly can similarly bevaried so that it may be deployed into planar triangular, square or ovalconfigurations as well. This closure assembly 156 also differs from theclosure assembly 32 and the closure assembly 131 in that it can beformed without the use of super-elastic or shape memory material.

Another embodiment of a closure device incorporating the presentinvention is shown in FIGS. 11, 12 and 13 in which a closure device 191is shown which is very similar to the closure device shown in FIG. 7with the exception that the closure assembly carried by the distalextremity 24 of the flexible elongate tubular member 22 is of adifferent construction from the closure assembly 156. The closureassembly 196 differs from the closure assembly 156 in that the distalextremity 24 of the flexible elongate tubular member 22 carries anadditional segment 192 of flexible elongate tubular material which hasbeen bonded or annealed to the tip 31 of the distal extremity 24 of theflexible elongate tubular member 22 and which forms a part of a closuremechanism 197 which is covered by an impermeable flexible membrane 198.The additional segment 192 is constructed of a segment of flexibleelongate tubular member which is extruded with only a main circular incross-section first lumen and without an additional lumen. The secondlumen 27 in this device 191 is blocked by the bonded or annealedadditional segment 192 and thus no plug is required. To form the closuremechanism 197, the additional segment 192 of the flexible elongatetubular member 22 is provided with a plurality of circumferentiallyspaced apart longitudinally extending slits 201 of a suitable number toprovide a plurality of arcuate segments as for example the four segments24a, 24b, 24c and 24d as shown in FIGS. 11 and 12. As hereinafterdescribed since the segments 24a, b, c and d are formed of a flexiblematerial, they can be bowed outwardly. The closure assembly 196 alsoincludes a plurality of rod-like elements 202 similar to the rod-likeelements 161 and formed of a suitable material such as stainless steelor Nitinol but because of the use of the arcuate segments 24a, b, c andd the rod-like elements 202 need only be approximately one-half thelength of the rod-like elements 161. The rod-like elements 202 like therod-like elements 161 can have a suitable diameter as for example 0.002"to 0.015" or preferably 0.002" to 0.003". The rod-like elements 202 areprovided with proximal and distal ends 203 and 204. The proximal endsare embedded in the arcuate segments 24a, b, c and d in a suitablemanner. For example, the plastic forming the segments can be extrudedover the ends 203 or, alternatively, the segments can be provided withbores for receiving the ends 203 which are secured therein by suitablemeans such as an adhesive (not shown). The rod-like elements 202 extenddistally and inwardly to form a truncated cone and have their distalends 204 interconnected by a generally hemispherical tip 206 formed ofsolder or a weld which is also bonded to the distal extremity 43 of thepush-pull wire 41 as shown in FIG. 11. The rod-like elements 202 areprovided with notches or weakened regions or memorized bending points toform hinge points 208 which are preferably in close proximity to thearcuate segments 24a, b, c and d so that the hinge points are close tothe junctures between the ends 203 and the adjoining segments 24a, b, cand d. The length of each of the arcuate segments 24a, b, c and d andeach of the rod-like elements 202 is approximately equal and correspondsto the desired size of the closure mechanism 197.

The membrane 198 covers the closure mechanism 197 and has a conformationsimilar to that of the membrane 158 and is provided with a closed end211 which overlies the hemispherical tip 206 and an open endcircumscribed by a rim 212 which is adhered to the additional portion192 of flexible elongate tubular material annealed to the tip 31 of thedistal extremity 24 of the flexible elongate tubular member 22 justproximal of the slits 201 which form the segments 24a, 24b, 24c and 24dand is secured thereto by a suitable means such as an adhesive (notshown).

Operation and use of the closure device 191 as shown in FIGS. 11 and 12is very similar to that described for the embodiment of the closuredevice 151 shown in FIG. 7. The closure device as shown in FIG. 11 hasthe closure assembly 196 in a de-deployed or un-expanded condition withthe button 47 being disposed in the notch 52. In connection with sealinga puncture after the distal extremity 24 of the device 191, and inparticular the closure mechanism 197, is disposed within the vessel 107distal of the puncture 106, the closure assembly 196 can be deployed bymoving the button 47 proximally to cause pulling on the pull wire 41 toapply compressive forces to the strut-like rod-like elements 202 tocause outward bowing of the same as well as the segments 24a, 24b, 24cand 24d with sharp bends occurring at the hinge points 208 just distalof the arcuate segments 24a, b, c and d. This outward bowing iscontinued so that the arcuate segments 24a, b, c and d are bentoutwardly with respect to the longitudinal axis of the flexible elongatetubular member 22 and similarly the rod-like strut elements 202 arebowed outwardly with respect to the hemispherical tip 206 while carryingalong with them the flexible impermeable membrane 198 until the rod-likeelements 202 substantially overlie and are generally parallel with thesegments 24a, b, c and d as shown in FIGS. 13 and 14 to form a planardisk-like conformation corresponding generally to the disk-likeconformations of the embodiments of the closure devices hereinbeforedescribed. Although the conformation as viewed in FIG. 14 has agenerally square configuration it can be readily appreciated that byproviding additional segments in the distal extremity 24 and acorresponding number of additional rod-like elements, additional armscan be provided for controlling the movement of the membrane 198 so thatthe outer margin of the membrane has a more generally circularconfiguration if that be desired. As heretofore described with otherembodiments, the configuration may also be oval, triangular or squaredepending on the number of elements.

After the closure assembly 196 has been deployed as shown in FIGS. 13and 14 it can be utilized in the manner hereinbefore described with theprevious closure devices for forming a seal with the inner surface ofthe wall 103 and thereafter introducing a biological sealant. After thishas been accomplished, the closure assembly 196 can be contracted andde-deployed by moving the button 47 from the notch 51 and pushing itdistally to push the hemispherical tip 206 distally and to cause inwardcollapsing of the segments 24a, b, c and d and the rod-like strutelements 202 until they have been moved into the original de-deployed orcontracted positions as shown in FIG. 11 and with the button 47 in thenotch 52. Thereafter, the closure device 191 can be retracted in amanner similar to that hereinbefore described with respect to theprevious embodiments.

Another embodiment of a closure device incorporating the presentinvention is shown in FIGS. 15 and 16. The closure device 221 showntherein is similar to that shown in FIG. 1 with the principaldifferences being that the device 221 utilizes a closure assembly on thedistal extremity 24 of the flexible elongate tubular member 22 and adeployment means that incorporate elements that are similar to both thedevice shown in FIG. 1 and the device shown in FIGS. 7-10. The closureassembly 222 consists of a closure mechanism 223 and an imperviousmembrane 224 which covers the closure mechanism 223. The closuremechanism 223 can be formed of the same super-elastic or shape memorymaterial as the closure mechanism 34 but rather than having a coil-likeconfiguration it consists of a plurality of circumferentially spacedapart rod-like elements 226 or arms of at least three in number havingproximal and distal ends 227 and 228. Thus each rod-like element 226 canbe similarly formed of Nitinol ribbon or wire and is annealed with anapproximate 180 degree fold located at the midpoint 229 between theproximal 227 and distal 228 ends so that when in a free state theelement 226 tends to fold at the midpoint 229 causing the proximal anddistal halves 231 and 232 of the rod-like element 226 to substantiallyoverlie one another in a single plane. Means is provided to secure theproximal end 227 of each rod-like element 226 to the deploymentmechanism 230 in a manner hereinafter described. The distal ends 228 ofthe rod-like elements 226 are fastened together in a suitable mannersuch as by welding or soldering to provide a generally hemispherical tip233 which is also secured to the deployment mechanism 230 in a mannerhereinafter described. Similar to the closure device 151 shown in FIGS.7-10, the lengths and number of the rod-like elements 226 may beselected to correspond to a selected diameter and shape of the closuremechanism 223.

The membrane 224 which forms a part of the closure assembly 222 can beformed of the same material as the membrane 36 and can be secured in thesame manner to the tubular member 22 so that it is provided with foldsand functions in the same manner as the membrane 36.

The deployment mechanism 230 consists of a push-pull wire 234 formed ofa suitable material such as stainless steel which is slidably disposedin the first or main lumen 26 and has proximal and distal extremities236 and 237 similar to the push-pull wire 41 with the principaldifference being that during formation the push-pull wire 234 isprovided with a central lumen or bore 238 extending from the proximalextremity 236 to the distal extremity 237. The push-pull wire 234 has asuitable outside diameter of approximately 0.020" (0.5 millimeters) andan inside diameter of approximately 0.010" (0.25 millimeters). Means isprovided for circumferentially securing the proximal ends 227 of therod-like elements 226 to the distal extremity 237 of the push-pull wire234 with the secured proximal ends 227 of the elements 226 being equallyspaced apart over 360 degrees and with the vertex of each midpoint 229fold directed outwardly and consists of similar welds or solder formingjoints 239 and 241. The proximal end 236 of the push-pull wire 234extends out of the proximal extremity 23 of the flexible elongatetubular member 22 and is connected to a handle assembly 242 in a mannersimilar to the device 21. The deployment mechanism 230 includes asecond, smaller pull wire 243 which is slidably mounted or disposedwithin the central lumen 238 of the larger push-pull wire 234 and isprovided with proximal and distal extremities 244 and 246. The pull wire243 is similarly formed of a suitable material such as stainless steeland has a suitable diameter as for example 0.005" to 0.030". Means isprovided for securing the distal extremity 246 of the pull wire 243 tothe hemispheric tip 233 and consists of soldering or welding. Theproximal end 244 of the smaller pull wire 243 also extends out of theproximal extremity 23 of the flexible elongate tubular member 22 and isoperatively connected to the handle assembly 242 which, in addition tocarrying means for causing longitudinal movement of the push-pull wire234 hereinbefore described and shown in FIG. 1, also carries means forcausing movement of the pull wire 243 along the longitudinal axisindependent of the movement of the push-pull wire 234 in a mannerhereinafter described.

The handle assembly 242 is similar to the handle assembly 44 with theprincipal difference being that the handle assembly 242 also providesaccess to the proximal end 244 of the smaller pull wire 243. Theprotrusion 247 of handle assembly 242 and means of securing thepush-pull wire 234 to the same is similar to protrusion 48 but theprotrusion 247 is also provided with a lumen 248 extending from theproximal end 249 to the distal end 251 of the protrusion 247 and alignedwith the central lumen 238 of the proximal extremity 236 of thepush-pull wire 234. A handle lumen 250 is provided which extendsproximally from the proximal end of the handle slot 255 and is alignmentwith both the slot 255 and the proximal end 249 of the lumen 248 in theprotrusion 247. The handle lumen 250 is provided with an aperture 252 atthe proximal end of the handle 242. The proximal end 244 of the smallerpull wire 243 extends proximally out of the proximal end 236 of thepush-pull wire 234 into and through the lumen 248 of the protrusion 247and through the handle lumen 250 slidably extending proximally out ofthe handle assembly 242 through the aperture 252. Means for fixing theproximal end 244 of the pull wire 243 in a particular position isprovided as for example with a simple releasable clamp or knob 253 thatprevents the pull wire 243 from sliding distally.

Operation and use of the closure device 221 may now be briefly describedas follows. It should be appreciated that operative positions of thebutton 254 for operation and use of the closure device 221 are similarto positions for button 47 in the closure device 21 shown in FIG. 1. Aclosure device 221 can be introduced into the sheath 111 in theun-expanded cylindrical or de-deployed configuration shown in FIG. 15 inthe manner hereinbefore described with respect to the device 21. Theclosure assembly 222 also can be deployed and de-deployed in a similarmanner with the principal difference being the additional steps ofdeploying and de-deploying the pull wire 243 in a manner hereinafterdescribed. After the button 254 is similarly utilized to initiate andmaintain deployment of the closure assembly 222 by pushing the closuremechanism 223 out of the distal extremity 24 of the flexible elongatetubular member 22, the rod-like elements 226 and the membrane 224 assumea configuration which is substantially in the form of a disk or aflattened circle, the shape being partially determined by the number ofthe rod-like elements 226. In order to assure assumption of asubstantially flat planar configuration by the closure assembly 222 thesmall pull wire 243 is then pulled proximally and fixed in position byusing the clamp 253, while the push-pull wire 234 is held stationary, tocause a pulling force to be applied to the hemispherical tip 233 tocause a pushing force to be applied to the rod-like elements 226 tocause them to further fold about their midpoints 229 so that theproximal and distal halves 231 and 232 of the elements 226 substantiallyoverlie one another in a single plane at a substantially right angle tothe longitudinal axis of the flexible elongate tubular member 22.Thereafter the procedure hereinbefore described can be used forestablishing a seal of the puncture 106 and to permit introduction ofthe biological sealant. After this procedure has been completed, theclosure assembly 222 can be de-deployed by releasing the clamp 253,permitting the small pull wire 243 to be pushed distally and thensimilarly completing the de-deployment sequence as hereinbeforedescribed for closure device 21.

It should be appreciated that additional variations of the pull wireassembly may be utilized as for example means may be provided formounting the pull wire within the lumen of the push-pull wire so thatthe position of the pull wire is fixed in relation to the longitudinalaxis of the flexible elongate tubular member so that with independentlongitudinal movement of the push-pull wire a similar pulling force issimultaneously applied to the hemispherical tip to cause a pushing forceto be applied to the rod-like elements as hereinbefore described.

It should also be appreciated that other embodiments may incorporateclosure assemblies utilizing arcuate segments similar to those shown inFIGS. 11, 12 and 13, absent rod-like elements wherein the distal tip ofthe push-pull wire is bonded directly to the tip of the distal extremityof the flexible elongate tubular member so that with proximal tractionon the push-pull wire compressive forces applied to the arcuate segmentscause outward bowing of the same with bends or folds occurring at themidpoints of the segments. An additional closure assembly may include aclosure mechanism constructed of super-elastic or shape memory alloythat is deployed by pushing the closure mechanism distally out of thedistal extremity of the flexible tubular member and then causing thesuper-elastic or shape memory alloy mechanism to be twisted by turningthe proximal end of the push-pull wire. In various embodiments theimpermeable membrane may also be secured directly to the closuremechanism instead of being secured to the distal extremity of theflexible elongate tubular member. Alternatively the membrane may beconfigured so to only partially cover the closure mechanism as forexample only the proximal side of the deployed closure mechanism.

Another embodiment of an expansile or closure device incorporating thepresent invention is shown in FIGS. 18-19. The device 301 shown thereinconsists of a first elongate tubular member 302, preferably a flexibleelongate tubular member 302, formed of a suitable plastic material,preferably a cast thermoset material such as polyimide. The firstflexible elongate tubular member 302 has proximal and distal extremities303 and 304 with a longitudinal axis extending from the proximal 303 tothe distal extremity 304 and is provided with a first lumen 306 circularin cross-section which, as shown, may be centrally disposed extendingfrom the proximal extremity 303 to the distal extremity 304. Both theouter and inner surfaces of the polyimide member 302 may be coated witha lubricious material such as Teflon™. Alternatively, the thermosetmaterial may be a polyimide-Teflon™₋₋ or polyimide-Nylon-Teflon™₋₋composite in order to provide the desired lubricious inner and outersurfaces. The first flexible elongate tubular member 302 has an outsidediameter ranging from approximately 0.008" to 0.050", preferablyapproximately 0.018". The first flexible elongate tubular member 302 hasa suitable length as for example 10-150 centimeters. The first lumen 306in the first flexible elongate tubular member 302 may have an insidediameter of approximately 0.003" to 0.030", preferably 0.012".

Expansile means in the form of an expansile assembly 307 is carried bythe distal extremity 304 of the first flexible elongate tubular member302 and is movable between contracted and expanded positions. Adeployment mechanism 308 is carried by the proximal extremity 303 of thefirst flexible elongate tubular member 302 and adapted to be operated bythe human hand for movement from a contracted position to an expanded ordeployed position.

The assembly 307 includes a expansile member 309 and a membrane 311which covers the expansile member 309. The expansile member 309 as shownin FIG. 19 is in a form having a complex geometrical configuration,preferably a helical coil configuration 312, when in a free state. Thehelical coil 312 is formed of a suitable material, preferably Nitinol,which can be elongated or constrained without permanent deformation but,at body temperature, when freed or unconstrained returns to the helicalcoil configuration to which it has been annealed. The helical coil 312has a plurality of generally circular turns creating, preferably, aproximal turn 313, a middle turn 314 and a distal turn 316. Theproximal, middle and distal turns 313, 314, 316 are generally nonplanarwith respect to one another. The proximal and distal turns 313 and 316each lie in a plane that is generally parallel to one another andgenerally perpendicular to the longitudinal axis of the first flexibleelongate tubular member 302. The middle turn 314 is non-planar andhelical as it connects the proximal and distal turns 313 and 316 so thatthe unconstrained helical coil configuration assumes a bi-conical shape.

The middle turn 313, when freed or unconstrained, has a suitablediameter ranging from 2 to 10 millimeters and preferably 4 to 6millimeters is used. As hereinafter described, during deployment themiddle turn 313 is partially flattened and constrained by the membrane311 to assume a diameter ranging from 1 to 10 millimeters, preferably 11French, in order to overlap a puncture site to assist in occluding thepuncture site. The proximal and distal turns 313 and 316 are ofapproximately equal size and diameter ranging from 1 to 5 millimeters,preferably 2 to 3 millimeters. The unconstrained helical coil 312configuration has a distance from the proximal 313 to the distal turns316 of approximately 3 to 15 millimeters, preferably 5 to 8 millimeters.In the de-deployed configuration the helical coil 312 is retracted intothe first flexible elongate tubular member 302 and has a contracted,constrained diameter corresponding to the approximate diameter of theNitinol wire used to construct the expansile mechanism 309, ranging from0.002" to 0.010", preferably 0.005" to 0.006". The distal tip of theNitinol wire corresponding to the free end of the distal turn 316,preferably, carries an enlargement, as for example a small ball orflattened tip 310 so as to prevent puncture of the membrane 311 by thewire during operation of the device and so as to decrease friction ofthe tip 310 against the wall of the lumen 306 of the first flexibleelongate tubular member 302 out of which the expansile mechanism 309 ispushed as hereinafter discussed. The ball 310 may be formed by asuitable method such as arc welding, soldering, applying a polymer tothe wire or folding the tip of the wire.

The deployment means or mechanism 308 includes a push-pull element ormember 317 preferably in the form of a wire 317, with proximal anddistal extremities 318 and 319 which is slidably disposed in andextending through the first or main lumen 306. The push-pull element 317is formed of a suitable material such as stainless steel and has asuitable diameter as for example from 0.005" to 0.030", preferably0.010". The expansile member 309 and the push-pull element 317 may beseparately constructed and subsequently joined together utilizing one ofseveral different methods. The two may be bonded or soldered together.Preferably, in order to provide for optimal torque, the stainless steelwire 317 is ground to provide a tapered portion 317a formed on thedistal end 319. The tapered portion 317a is inserted into one end of anelongate member, often called a hypotube 320 made of an appropriatematerial such as stainless steel and adhesively bonded therein using anappropriate adhesive 325 such as Loctite™. The proximal end 318 of theNitinol wire expansile member 309 is similarly inserted and bonded intothe opposite end of the hypotube 320. The stainless steel hypotube 320may be of an appropriate length, such as from 2 to 15 cm, preferably 4.5cm. It may have an outer diameter ranging from 0.005" to 0.030",preferably 0.010" and an inner diameter ranging from 0.003" to 0.010",preferably 0.006".

Alternatively, both the push-pull wire 317 and the expansile mechanism309 can be formed from a single piece of Nitinol wire in which case, inorder to provide optimal pushability, torquability and column strengthof the push-pull wire 317, two alternative techniques are utilized.First, a Nitinol wire diameter of approximately 0.010" is used bygrinding down the distal end 319 to a diameter suitable for subsequentformation of the expansile member 309.

A second technique utilizes a Nitinol wire having a diameter suitablefor formation of the expansile mechanism 309. In such case, thepush-pull wire 317 is covered with a suitable polymer jacket, preferablymade of polyimide and having an diameter of approximately 0.005" to0.0101". The polymer jacket is thicker at the proximal end 318, neckeddown at the distal end 319 of the push-pull wire 317 and secured to thepush-pull wire 317 at distal and proximal ends by a suitable adhesivesuch as Loctite™.

As shown in FIG. 18 the proximal end 318 of the push-pull wire 317extends out of the proximal extremity 303 of the first flexible elongatetubular member 302 so that the deployment means can be operated by thehuman hand as hereinafter described.

It should also be appreciated that push-pull elements or mechanisms,other than a push-pull wire, can be utilized to deploy and de-deploy theexpansile member and the expansile assembly.

A stop mechanism or means 321 is provided to control the range ofmovement or travel of the push-pull wire 317 during deployment andde-deployment of the expansile assembly 307. The stop mechanism 321comprises first and second, slidable nested or coaxially mounted stoptubes 322 and 323 formed of an appropriate material such as plastic orstainless steel. The distal end of the first stop tube 322 carries abushing 324. The bushing 324 is secured to the distal end of the firststop tube 322 by suitable means such as an adhesive (not shown). Theproximal end 318 of the push-pull element 317 is affixed to the firsttube by suitable means such as an adhesive. The push-pull element 317with the first tube 322 affixed thereto and the bushing 324 carriedthereby is movable longitudinally of the second tube 323 which has itsdistal extremity secured to the proximal extremity 303 of the elongatetubular member 302. It is movable from a forward most position with thebushing 324 in engagement with the proximal end 303 and a rearwardmostposition in engagement with an annulus 326 mounted in the proximalextremity of the second tube 323 by suitable means such as an adhesiveand through which the first tube 322 slidably extends. The lengths ofthe first and second tubes 322 and 323 are selected so that the travelbetween the forwardmost and rearwardmost positions ranges between 2 cmand 10 cm.

The expansile assembly 307 also includes a deformable, flexible membrane311 which is carried by, and as shown, can be secured to the distalextremity 304 of the first flexible elongate tubular member 302 ashereinafter discussed. Since it is desired that this membrane 311 bevery flexible it has a wall thickness ranging from 0.001" to 0.015" andpreferably about 0.004". It can be formed of any suitable flexiblematerial such as an elastomeric or a non-elastomeric material includinglatex and silicone. The membrane 311 can also be made of an impermeableor a permeable material providing for multiple uses of the device. Asatisfactory membrane 311 can be made of Chemoprene™ or one of thepolyurethane elastomers such as Polyblend™ having a shore hardnessdurometer of 30 to 70A, and preferably 55A, Tecoflex™ having a shorehardness durometer of 60 to 100A or Pellathane™ having a shore hardnessdurometer of 70 to 100A. Alternatively the membrane 311 can be made ofmultiple layers including a central Polyblend™ layer having a thicknessof approximately 0.005" to 0.010" and a thin outer Tecoflex™ layerhaving a thickness of approximately 0.0005". This layered membrane 311is made by dipping the Polyblend™ in a Tecoflex™ solution, for example aTecoflex™ 85A solution. As shown, the membrane 311 is substantiallyimpermeable to blood and other liquids. It is formed as a tubular sock333 which has an elongate generally cylindrical configuration with oneclosed end 329 and the other end circumscribed by an opening 331 whichis defined by a rim 332 of the same material. The tubular sock 333 hasan appropriate length, as for example ranging from 2-15 mm, preferably 7mm. When the membrane 311 is made from Polyblend™, typically supplied ina tubular form and cut into lengths of appropriate dimensions with bothends open, the closed end 329 of the membrane 311 is formed by dippingone open end of the Polyblend™ into a Tecoflex™ solution, preferably 10%by weight of 85A Tecoflex™, to provide a sealing plug 327. The rim 332of the membrane 311 can be circumferentially secured to the distalextremity 304 of the first flexible elongate tubular member 302 in asuitable manner such as by the Loctite 454™ adhesive (not shown).

A length of stainless steel hypotube 328 has one end secured to thedistal end 304 of the first flexible elongate tubular member 302 (seeFIG. 18) using an appropriate adhesive such as Loctite 406™ The hypotube328 has an appropriate length ranging from 2 mm to 10 mm, preferably 5mm, and is secured to the first flexible elongate tubular member 302 andextends distally of the same by approximately 2-8 mm. The rim 332 of themembrane 311 is affixed exteriorly of the stainless steel hypotube 328by an adhesive (not shown), preferably, distal to the point at which thehypotube 328 is secured to the first flexible elongate tubular member302 and with the closed end 329 of the membrane 311 oriented distallythereon as shown in FIG. 18. As such, a portion of the membrane 311distal to the rim 332 overlies the steel hypotube 328 and isnon-adherent thereto. It should be appreciated if desired that the rim332 can be secured directly to the outer surface of the distal extremity304. In either arrangement, the membrane 311 assumes a sock-likeconformation as shown in FIG. 18. Alternatively, the rim 332 of themembrane 311 may be secured interiorly within the hypotube 328 or, ifthe hypotube 328 is not utilized, within the first or main lumen 306 ofthe first flexible elongate tubular member 302. In addition, themembrane 311 may be secured to the Nitinol wire proximal to theexpansile member 309.

The impermeable membrane 311 of the expansile assembly 307 can be causedto assume various configurations including a planar disk-likeconfiguration as shown by the dotted-line position in FIG. 18. This isaccomplished by operation of the deployment mechanism 308 to move thepush-pull element 317 distally to urge the expansile member 309 distallyout of the lumen 306 into the membrane 311. The operator can assistdeployment by applying a slight rotation to the push-pull element 317 asit is moved distally. As soon as the expansile member 309 clears thefirst lumen 306, it begins to expand into its shape memory,predetermined configuration. The distal turn 316 of the expansile member309 in the form of a coil operates to expand the membrane 311 initiallyto a small degree. This initial process avoids sudden gross distortionof the membrane 311. As the expansile member 309 moves distally out ofthe lumen 306 and expands into the membrane 311, the non-adherentportion of the membrane 311 distal to the rim 332 preferentially beginsto move and assume the planar configuration because of the lubricioussurface of the stainless steel hypotube 328. Expansion proceeds with themiddle turn 314 forming a coil and causing the membrane 311 to expand toits desired size, approximately 12 French. The proximal turn 313 forminga coil then centralizes and stabilizes the configuration so that thepush-pull element 317 is centered with respect to the middle turn 314and the fully expanded membrane 334. During expansion of the expansilemember 309 the membrane 311 covering the coil 312 constrains the coil312, thus exerting counteractive or countervailing contractile forces onthe expanding coil 312 which is seeking its memorized, bi-conical, freeshape or configuration 312. Thus, the membrane 311 does not expandpassively. Rather, the expanding coil 312 forcibly expands the membrane311 to cause the non-planar turns 313, 314 and 316 of the coil 312 toassume a substantially planar or disk-like configuration with themembrane 334 being taut and disposed on opposite sides of the expansilemechanism 309 to form an expansile assembly 307 which when expanded isgenerally perpendicular to the longitudinal axis of the first flexibleelongate tubular member 302. The expansile mechanism 309 when deployedis sufficiently rigid so as to provide a supporting framework for themembrane 311 to keep it taut.

It should be appreciated that other embodiments may be utilizedemploying superelastic expansile members with various memorizedconfigurations. In addition, as hereinbefore discussed, differentmembrane materials may be utilized in order to construct permeable orimpermeable assemblies for different functions. The predictability ofcountervailing, expansile forces and resistive, membrane forces enablesthe construction of expansile assemblies with predetermined, deployedconfigurations. In addition, instead of sliding a push-pull wire, theNitinol member can be secured to a wire which remains stationary. Insuch an embodiment, the expansile member and wire are sheathed within anelongate tubular member which has a sock-like membrane secured to thedistal end thereof and whence the member is deployed into the membraneby sliding the sheath proximally.

Operation and use of the device 301 is very similar to that describedfor the embodiment of the closure device 21 with the followingdifferences. The expansile device 301 shown in FIGS. 18-19 is not usedwith biological sealants. Thus, after bringing the expansile assembly307 into contact with the distal end of the puncture 106, a proximalforce of tension or traction is maintained on the expansile assembly 307for a predetermined period of time ranging from 2 minutes to severalhours, preferably 30 minutes to 1 hour, until the puncture 106 issealed. Release of the tension is followed by moving the expansileassembly 307 from the deployed or expanded position to the de-deployedor contracted position after which the device 301 may be removed ashereinbefore described.

A second difference is that the radio-opacity of the expansile mechanism309 is determined by the configuration of the coil 312. When it is inthe unconstrained, memorized, bi-conical configuration, the coil 312 isnot fluoroscopically visible due to the small size of the individualturns of the Nitinol wire and the non-planar configuration. When theexpansile mechanism 309 assumes the flat disk-like shape within themembrane 334 the cumulative densities of the Nitinol turns can befluoroscopically visualized. As hereinbefore discussed, this too is aneasy method of ascertaining or confirming formation of a good sealbetween the expansile assembly 307 and the wall 103 of the vessel 107.

Furthermore, the low profile of the device 301 affords the ability toreenter the vessel 107 with the introducer sheath 111 if there has beeninadequate occlusion and bleeding continues or other complicationsensue. For example, let it be assumed that the operator believes thepuncture 106 is sealed after removal of the sheath 111 and he thereforede-deploys the expansile assembly 307 as hereinbefore described. If,after so doing, he observes continued bleeding from the puncture 106,the operator can reenter the vessel 107 by releasing tension, pushingthe first flexible elongate tubular member 302 distally and reinsertingthe sheath 111 into the vessel 107 over the first flexible elongatetubular member 302. The operator can also reenter the vessel foradditional medical purposes if necessary. The same approach applies ifthe membrane 311 breaks or the expansile assembly 307 otherwisemalfunctions. In this case the sheath 111 is replaced as hereinbeforedescribed and the malfunctioning expansile device 301 is expeditiouslyreplaced.

A tension applicator or catheter retention means 335 is provided whichengages the elongate tubular member 302 and serves to releasably placetensioning forces on the elongate tubular member 302 to maintainengagement of the deployed expansile assembly 307 against the vesselwall 103 having a puncture 106 therein and to free the operator's handsfrom having to hold the device 301 after it is correctly deployed in thepuncture 106. The catheter retention means 335 provides a predeterminedand substantially constant force in a proximal direction on theexpansile member 309 over a range of motion or positions of the flexibleelongate tubular member 302 which may occur as a result of patientmovement or initial positioning.

The tensioning device 335 is shown in FIGS. 20-23 and consists of afixture 336 or bottom portion which is constructed of a suitablematerial such as clear plastic and comprises a base plate 337 having anappropriate shape and size, as by way of example a pear-shape and size,as shown in FIG. 20 and adapted to rest on the skin 101 overlying thepuncture 106 in the wall 103 forming the lumen 107. The fixture 336further comprises anterior and posterior walls 338 and 339 which extendupwardly, preferably at approximately right angles from the surface ofthe base plate 337. The posterior wall 339 has an outer face 342 that isstraight and an inner face 343 that is inclined. The anterior wall 338also has inner and outer faces 344 and 346 that are straight. Aswingable arm or top portion 347 is hingedly or pivotally mounted to thetop of the posterior wall 339 of the base portion 336 for movementbetween open and closed positions with respect to the base portion 336.In the open position, the top portion 347 may assume an angle of up to180 degrees, preferably 45 degrees, with respect to the base portion336. In the neutral or closed position, the top portion 347substantially overlies and is parallel to the base portion 337. Ashereinafter described however, in the closed position, the top portion347 is also capable of at least 0.5 cm of additional travel or motion inboth closed and open directions, both towards and away from the baseportion 336, respectively.

The arm 347 is hinged and biased or yieldably urged towards the openposition, away from the skin of the patient, by spring means capable ofproviding a predetermined and substantially constant tensioning forceover a range of positions. The top and bottom portions 347 and 336 ofthe tensioning device 335 can be constructed as one piece whichincorporates a living hinge 348 formed by scoring or placing a groove inthe plastic. Alternatively, a metal or other hinge can be utilized tojoin separate top and bottom portions. A constant force spring, such asa coil spring 349 capable of providing an appropriate constant force oftension is preferably utilized as hereinbefore discussed. It should beappreciated that any type of spring capable of providing theaforementioned constant force of tension can be used, as, by way ofexample, flat, leaf, spiral, helical, disk and volute springs.

As shown in FIG. 20, catheter clamping or grasping means in the form ofgrasping members 351 are carried by the arm 347 and are movable betweenopen or release, and closed or clamping positions. The grasping members351 are in the form of serrated pads constructed of an appropriatematerial, such as plastic, rubber or metal. The grasping members 351 arecarried by the distal extremities of flexible elongate curved springmembers or grasping arms 352. The arms 352 may be constructed of asuitable spring material such as plastic or metal and are disposed in arecess 350 of the casing of the top portion 347. The proximalextremities of the spring arms 352 are disposed on opposite sides ofspaced apart pins 352 mounted so that the proximal extremities arebiased towards each other into the clamping position.

Means are provided for overcoming the bias of the spring arms 352 andconsists of flanged actuator buttons 354 slidably mounted in holes.Actuator arms 355 are secured to the buttons 354 and extend one behindthe other to engage the opposite spring arm 352 (see FIG. 21) so thatthe spring arms 352 can be moved apart to move the grasping members 351to the open position.

The fixture and arm portions 337 and 347 may be formed with slots 356and 357 which are in alignment when the arm 347 is in the closedposition and in which the first elongate tubular member 302 or body 362is disposed when being grasped by the grasping members 351.

Operation of the tension applicator 335 may now be described inconjunction with FIGS. 21-23. By placing the fixture 336 against thepatient's skin and, as shown in FIGS. 22-23, urging or forcing the arm347 towards the fixture 336 until it comes into apposition with the baseplate 337 and opening the spring arms 352 in order to grasp the firstflexible elongate tubular member 302 or elongate tubular body 362, thetensioning device 335 can be set or activated whence it maintains asuitable, constant proximal force of tension, preferably within a rangeof 0.25 to 3 pounds, over a range of motion. The force applied to thefirst flexible elongate tubular member 302 attempts to withdraw themember 302 from the puncture 106 in the wall 103 of the vessel 107 sothat the expansile device 302 is retained in engagement with the wall103 of the vessel 107.

Indicator marks in the form of arrows 358 are placed on the fixture 336and the arm 347 so that the marks are aligned with one another when thetensioning means 335 is correctly positioned and activated in theneutral, closed position as hereinbefore described. Alternatively,visualization through the clear plastic base plate 337 can serve asindicator means.

It should be appreciated that other embodiments of the tensionapplicator or tensioning device may be utilized in the present inventionwithout departing from the novelty and the intended uses thereof. Forexample, the grasping means can be comprised of asymmetrical members andarms, similar to a pin vise or clamp. In such an embodiment one graspingarm is slidably disposed within another and can be spring loaded orotherwise biased into a position in which one grasping member is apposedwith the other grasping member. Alternatively, two grasping arms may beconstructed from a single arm which has been partially split along itslongitudinal axis, providing arms that splay apart. Grasping members mayalso be comprised of clamps that snap or roll into closed positions.Similarly, the arm may have a length that is shorter than the bottomportion and beyond which the grasping members and arms extend. It shouldalso be appreciated that the tension applicator 335 can be used withother catheters.

The tensioning device 335 with its indicators also serve to confirmformation of a good, occlusive seal of the puncture 106 with theexpansile assembly 307. The deployed expansile assembly 307 withstandsthe aforementioned proximal force or tension and in so doing maintainsthe occlusive seal unless the deployed coil 312 and disk-shaped membrane334 change configurations. For example, if the membrane 311 breaks, thecoil 312 once again assumes its memorized bi-conical configuration 312which cannot maintain a high tensile force and is incompatible withpuncture occlusion. As tension is lost the indicator on the tensioningdevice 335 is activated, alerting the operator to the release of thepredetermined force of tension and lack of an adequate seal.

Another embodiment of the tensioning device is shown in FIG. 33. Thetensioning device 380 is similar to that shown in FIG. 20 with theprincipal exception being that the device 380 provides a variable forcein a proximal direction on the expansile member 309 over a range ofmotion or positions of the first flexible elongate tubular member 302which may occur as a result of patient movement or initial positioning.Thus, all of the parts of the tensioning member 380 that are present inthe tensioning member 335 carry the same numbers. The tensioning device380 is constructed of a suitable material such as plastic and,preferably, comprises an injection molded, one piece body having a baseplate 337, an arm 347, a spring member 349 connecting said arm 347 tothe base 337 and grasping members 351 carried by the arm 347.

The base plate 337 has anterior and posterior ends 381 and 382 andcomprises two legs 383 with a slot 356 therebetween. The base 337 has anappropriate shape, as for example a vee shape as shown in FIG. 33, withthe two legs 383 joined at the posterior end 382 of the base 337.

The spring 349 is a linear spring comprising a ribbon shaped plasticmember which is configured substantially as a cee having ends which jointhe posterior base 382 to the arm 347 to form a continuous body ashereinbefore described. In the open position, the vertical distancebetween the anterior end 381 of the base 337 and the arm 347 ranges from0.5-2.5", preferably being approximately 1.5". The spring 349 isconstructed so as to provide increasing tension with increasingcompression which results from moving the arm 347 towards the base 337.Thus, as hereinafter described, the force of tension provided therebyranges between 0.25-10 ounces, preferably between 0.5-2.5 ounces.

When the tensioning device 380 is set in the closed position so that thearm 347 and base 337 are disposed substantially parallel to one another,the spring 349 is under a force of tension of approximately 1 ounce.Movement of the arm 347 an additional 1 centimeter towards the base 337increases the spring tension to approximately 2 ounces. Similarly,setting the tensioning member 380, or movement of the patient, so thatthe arm 347 is disposed approximately 1 centimeter above a planeparallel with the base 337 provides a force of tension of approximately0.5 ounces.

As shown in FIG. 33, the arm 347 has anterior and posterior ends 384 and385, the anterior end 384 carrying an enlarged, bulbous portion 386having a slot 357 therein, the slot 357 being anteriorly-posteriorlydisposed and substantially in alignment with the slot 356 in the baseportion 337 when the tensioning member 380 is closed. The enlargedportion 386 is divided by the slot 357 into two grasping members 351which are movable between open or release, and closed, or grasping,positions. When an elongate tubular member is disposed in the slot 357and grasped by the grasping members 351 as hereinafter described, thegrasping members 351 are biased into the closed position with a forceapproximating 5 ounces as a result of the slot 357 having a diameterthat is slightly smaller than the diameter of either the first elongatetubular member 302 or the second elongate tubular member 503.

The bias of the grasping members 351 is overcome, and the slot 357thereby opened, by the use of actuator finger grips 387 which extendoutwardly and posteriorly from the enlarged portion 386 of the anteriorend 384 of the arm 347. The grips 387 are provided with fingerindentations 388 for use as hereinafter described.

Operation of the tensioning applicator 380 is similar to that ofapplicator 335. By placing the applicator 380 against the patient's skinand urging the arm 347 towards the base 337 until the two aresubstantially parallel to one another and opening the grasping members351 by pressing inwardly on the finger indentations 388 of the actuatorgrips 387 in order to grasp either the first or second elongate tubularmember 302 and 503, the tensioning applicator 380 can be set toapproximately 1 ounce of tension as hereinbefore described.

The grasping members 351 are constructed to exert a maximum force ofapproximately 5 ounces so that a grasped elongate tubular member ispermitted to slide between the grasping members 351 if a force ofgreater than approximately 5 ounces is longitudinally applied to thetubular member.

The remainder of the operation of the tensioning device 380 is ashereinbefore described.

Another embodiment of the expansile device is shown in FIG. 24. Theexpansile device 360 is very similar to that shown in FIG. 18 with theprincipal difference being that, in addition, it provides means forintroducing a biological sealant into the puncture proximal to theexpansile mechanism to seal the puncture. Thus all the parts of theexpansile device 301 that are present in the expansile device 360 carrythe same numbers. The biological sealant introducer means 361 is carriedby a flexible elongate tubular body 362 comprising first and secondflexible elongate tubular members 302 and 363. The first flexibleelongate tubular member 302 is as hereinbefore described. The secondflexible elongate tubular member 363 is formed of suitable plasticmaterial, preferably an extruded thermoplastic elastomer such as Pebax™having a shore hardness durometer of 50D or 72D. The second flexibleelongate tubular member 363 has proximal and distal extremities 364 and366, extends along a longitudinal axis and has an inner wall 367defining a lumen 368 extending from the proximal 364 to the distalextremity 366. The lumen 368 has a diameter greater than the outerdiameter of the first flexible elongate tubular member 302. The firstflexible elongate tubular member 302 is disposed or nested within thelumen 368 of the second flexible elongate tubular member 363 therebydefining a first, circumferential or annular space 369 between the outersurface of the first flexible elongate tubular member 302 and the innerwall 367 of the second flexible elongate tubular member 363. The distalextremity 366 of the second flexible elongate tubular member 363terminates proximal to the distal extremity 304 of the first flexibleelongate tubular member 302 and adjacent to the expansile mechanism 309.

The second flexible elongate tubular member 363 is of a suitable size,as for example an outer diameter ranging from 0.020" to 0.050", an inneror lumen diameter ranging from 0.015" to 0.040" and has a suitablelength as for example 10-160 centimeters. As hereinbefore discussed, thedistal extremity 366 of the second flexible elongate tubular member 363terminates proximal to the distal extremity 304 of the first flexibleelongate tubular member 302 and adjacent to the expansile mechanism 309,as for example 1-15 millimeters up to several centimeters proximal.

Proximal adaption for sealant introduction into the flexible elongatetubular body 362 includes appropriate tee or wye adapters. Preferably,as shown in FIG. 24, a tee adapter 375 has one end fixed to the proximalextremity 364 of the second flexible elongate tubular member 363 using asuitable adhesive. The second end of the tee adapter 375 carries acompression fitting 376 in order to accommodate the proximal end 303 ofthe first flexible elongate tubular member 302 which is disposed withinand extends proximally out of the tee adapter 375. The compressionfitting 376 provides a leakproof connection between the first and secondflexible elongate tubular members 302 and 363 and enables removal of thesecond flexible elongate tubular member 363 while the first flexibleelongate tubular member 302 is maintained in the deployed position.Introduction of sealants is accomplished via a fluid port 377 whichcommunicates with the proximal end 364 of the second flexible elongatetubular member 363 as shown in FIG. 22. An alignment window 378 in thetee adapter 375 is provided which is used to visually align a marker 379on the proximal extremity 303 of the first flexible elongate tubularmember 302 or on the proximal extremity 318 of the push-pull wire 317 sothat the distal extremity 366 of the second flexible elongate tubularmember 363 is appropriately positioned proximal to the distal extremity304 of the first flexible elongate tubular member 302 and adjacent tothe expansile mechanism 309 as hereinbefore described.

Operation and use of the device 360 is similar to that described for theexpansile device 301 except for the ability to introduce biologicalsealants with the device 360. As soon as it has been established that agood seal has been formed between the occlusion assembly 307 and thewall 103 adjacent the puncture the operator can introduce theconstituents of the biological sealant into the fluid port 377 of theadapter 375 hereinbefore described. The sealant is then introduced intothe proximal end 364 of the second flexible elongate tubular member 363into the first space 369 between the outer surface of the first flexibleelongate tubular member 302 and the inner wall 367 of the secondflexible elongate tubular member 363, thence exiting proximal to thedistal extremity 304 of the first flexible elongate tubular member 302and adjacent to the expansile mechanism 309. The remainder of theoperation of the device 360 is as hereinbefore described in conjunctionwith the use of the device 21 and the device 301.

Another embodiment of a expansile device incorporating the presentinvention is shown in FIGS. 25-26. The expansile device 401 is verysimilar to that shown in FIG. 24 with the principal difference being inthe biological sealant means utilized in the device 401. Thus all of theparts of the expansile device 360 that are present in the expansiledevice 401 carry the same numbers. The biological sealant means 402 isalso similar to that shown in FIG. 24 with the principal differencebeing that the flexible elongate tubular body 362 further includes athird flexible elongate tubular member 403 formed of suitable plasticmaterial, also preferably an extruded thermoplastic elastomer such asPebax™ having a durometer of 63D or 72D. The third flexible elongatetubular member 403 has proximal and distal extremities 404 and 406,extends along a longitudinal axis and has an inner wall 407 defining alumen 408 extending from the proximal 404 to distal extremity 406 andhaving a diameter greater than the outer diameter of the second flexibleelongate tubular member 363. The second flexible elongate tubular member363 is nested or disposed within the lumen 408 of the third flexibleelongate tubular member 403 thereby defining a second, circumferentialor annular space 409 between the second flexible elongate tubular member363 and the inner wall 407 of the third flexible elongate tubular member403. The distal extremity 406 of the third flexible elongate tubularmember 403 terminates distal to the distal extremity 366 of the secondflexible elongate tubular member 363 and proximal to the distalextremity 304 of the first flexible elongate tubular member 302 therebydefining an annular distal mixing chamber 411 between the first flexibleelongate tubular member 302 and the inner wall 407 of the third flexibleelongate tubular member 403.

The third flexible elongate tubular member 403 is of a suitable size, asfor example an outer diameter ranging from 0.030" to 0.070", and has asuitable length as for example 10-160 centimeters. As hereinbeforediscussed, the distal extremity 406 of the third flexible elongatetubular member 403 terminates distal to the distal extremity 366 of thesecond flexible elongate tubular member 363, as for example from 1-15millimeters distal, preferably 5 millimeters, thus creating the distalmixing chamber 411. The distal extremity 406 of the third flexibleelongate tubular member 403 also terminates proximal to the distalextremity 304 of the first flexible elongate tubular member 302 andadjacent to the expansile mechanism 309, as for example 1-15 millimetersup to several centimeters proximal. In order to affect thisconfiguration, the second flexible elongate tubular member 363 may be ofa suitable length that is slightly shorter than the length of the secondflexible elongate tubular member 363 in device 360.

Proximal adaption for sealant introduction into this triple flexibleelongate tubular member body is provided so that either the secondflexible elongate tubular member 363 or the second and third flexibleelongate tubular members 363 and 403 can be reversibly disengaged andremoved. Removing the second flexible elongate tubular member 363provides access to a larger space between the first and third flexibleelongate tubular members 302 and 403 in order to provide for morereliable aspiration attempts. Removing both the second and thirdflexible elongate tubular members 363 and 403 provides for use of theisolated expansile device 301 as hereinbefore discussed, and alsopermits cleaning of the removed tubular members as necessary.

The proximal adaption for the device 401 includes appropriate tee or wyeadapters as hereinbefore described. The proximal adaption 375 for thesecond flexible elongate tubular member 363 is similar to the proximaladaption 375 for the second flexible elongate tubular member 363 indevice 360. The third flexible elongate tubular member 403 carriessimilar proximal adaption 412 in the form of a tee adapter 412,compression fitting 413 and a fluid port 414 so that, as hereinbeforediscussed, the second flexible elongate tubular member 363 can bedisposed or nested within the third flexible elongate tubular member 403with a proximal seal between the two members that is fluid-tight. Asecond sealant or component thereof can be introduced into the fluidport 414 of the compression fitting 413 on the third flexible elongatetubular member 403 as hereinafter discussed.

In addition, the proximal adapter 412 of third flexible elongate tubularmember 403 carries an alignment window 416 in order to permit theoperator to visually align a marker 417 on the second flexible elongatetubular member 363 within the window 416 so that during use the secondand third flexible elongate tubular members 363 and 403 areappropriately positioned with respect to one another. It should beappreciated that second and third flexible elongate tubular members 363and 403 can be constructed as a single unit whereby only the unit iscapable of being inserted and removed over the first flexible elongatetubular member.

Operation and use of the device 401 is similar to that described for theexpansile device 360 except for use of the biological sealant means 402in the device 401. As soon as it has been established that a good sealhas been formed between the occlusion assembly 307 and the wall 103adjacent the puncture the physician can introduce the constituents ofthe biological sealant into the fluid port 377 of the adapter 375 on theproximal end 364 of the second flexible elongate tubular member 363 intothe first space 369 and into the fluid port 414 of the adapter 412 onthe proximal end 404 of the third flexible elongate tubular member 403into the second space 409 respectively, causing the constituents totravel separately, distally into the distal mixing chamber 411 wherethey are well mixed and whence the mixed sealant exits proximal to thedistal extremity 304 of the first flexible elongate tubular member 302and adjacent to the expansile mechanism 309. The remainder of theoperation of the device 401 is as hereinbefore described in conjunctionwith the use of the device 21.

Another embodiment of a expansile device incorporating the presentinvention is shown in FIGS. 27-30. The expansile device 418 is also verysimilar to that shown in FIG. 24 with the principal difference being inthe biological sealant means 419 utilized in the device 418. Thus all ofthe parts of the expansile device 360 that are present in the expansiledevice 418 carry the same numbers.

The second flexible elongate tubular member 363 of the device 418 isprovided with an additional or second lumen 425 which may behalf-circular in cross-section, is laterally disposed and also extendsfrom the proximal extremity 364 to the distal extremity 366 of thesecond flexible elongate tubular member 363 as shown in FIG. 27. Inorder for the second flexible elongate tubular member 363 to carry thesecond lumen 425, the first lumen 368 may also be laterally disposed.The second lumen 425 has a suitable chord length ranging from 0.020" to0.040".

The second lumen 425 of the device 418 may be utilized for introducingbiological sealants as hereinbefore described in conjunction with thedevice 360. The second lumen 425 can also be used for aspirationattempts, to verify formation of a good seal between the expansileassembly 307 and the wall 103 of the vessel 107 has hereinbeforedescribed in conjunction with the device 21.

The expansile device 418 is also provided with a third flexible elongatemember 430 having proximal and distal extremities 431 and 432 andextending along a longitudinal axis. Shown in FIGS. 27-28 and FIG. 30,the third flexible elongate member 430 is sized and shaped to bereversibly, frictionally disposed within the second lumen 425 of thesecond flexible elongate tubular member 363 and has a lengthsubstantially equal to the length of the second flexible elongatetubular member 363.

The third flexible elongate member 430 is similarly formed of a suitableplastic material such as Pebax™ and is solid in construction, as shownin FIG. 28, so that it functions as an obturator for the second lumen425 of the second flexible elongate tubular member 363, thus keeping thesame unobstructed until ready for use.

There is provided an alternate third flexible elongate member 433 whichis similarly sized and shaped and functions as a biological sealantintroducer means. As shown in FIGS. 27 and 30, this alternate thirdflexible elongate member 433 carries first and second lumens 434 and436, each extending from the proximal to the distal extremity 431 and432 of the alternate third flexible elongate member 433. A mixingchamber 437 contiguous with and created by the distal confluence of thefirst and second lumens 434 and 436 is carried by the distal extremity432 of the third flexible elongate member 433. Alternatively, the thirdflexible elongate member 433 can be without the aforementioned distalconfluence of lumens and, in place thereof, have a length slightlyshorter than that of the second flexible elongate tubular member 363 sothat a mixing chamber 437 is created within the distal end 366 of thesecond flexible elongate tubular member 363.

Proximal adaption 438 for sealant introduction into this third flexibleelongate member 433 is provided as shown in FIG. 27. The proximalextremity 431 of the third flexible elongate member 433 carries afitting or adapter 438 having two or more fluid ports 439 in alignmentwith the first and second lumens 434 and 436 of the third flexibleelongate member 433. The fitting 438 is constructed out of a suitablematerial such as plastic or nylon, by way of example, polycarbonate orIsoplast™, and is bonded to the third flexible elongate member 433 by anappropriate adhesive. Alternatively, the adapter 438 can be constructedof Pebax™ 82D, and be heat fused to the proximal end 431 of the thirdflexible elongate member 433. It should be appreciated that the adapter438 may be constructed so as to be reversibly connected to the thirdflexible elongate member 433.

Operation and use of the device 418 is similar to that hereinbeforediscussed in conjunction with the device 401. Constituents of biologicalsealants are introduced proximally into the adapter 438 and thence intothe first and second lumens 434 and 436 causing the constituents totravel separately, distally into the distal mixing chamber 437 wherethey are well mixed and whence the mixed sealant exits proximal to thedistal extremity 304 of the first flexible elongate tubular member 302and adjacent to the expansile mechanism 309.

Alternately, as shown in FIGS. 31-32, a third flexible elongate tubularmember 450 is provided which, other than being tubular in shape, issimilar in construction to the alternate third flexible elongate membershereinbefore discussed. This third flexible elongate tubular member 450is also sized to be frictionally disposed within the second lumen 425 ofthe second flexible elongate tubular member 363 in which case the areain the second lumen 425 of the second flexible elongate tubular member363 surrounding the third flexible elongate tubular member 450 is usedas a second space 451 into which biological sealants are introduced ashereinafter discussed.

Proximal adaption for sealant introduction into the second lumen 425 ofthe second flexible elongate tubular member 363 and the third flexibleelongate tubular member 450 is provided as shown in FIG. 31. Theproximal extremity 364 of the second flexible elongate tubular member363 carries a fitting or adapter 452 constructed in a manner similar tothat hereinbefore discussed. The adapter 452 has proximal and distalends 453 and 454 and carries a variably-shaped lumen 456 extendingtherethrough. The distal end 454 of the adapter lumen 456 is sized,configured and aligned with the second lumen 425 of the second flexibleelongate tubular member 363. The proximal end 453 of the adapter lumen456 is circular in cross-section and is sized so as to frictionallyaccept the third flexible elongate tubular member 450. A fluid port 457is connected to the adapter lumen 456. As shown in FIG. 31, the proximalend 431 of the third flexible elongate tubular member 450 also carries afluid port 458. The third flexible elongate tubular member 450 is of aslightly shorter length than that of the second flexible elongatetubular member 363 in order to create the distal mixing chamber 437 ashereinbefore discussed. Operation and use is as hereinbefore described.

Alternatively, instead of utilizing a third flexible elongate member thesecond flexible elongate tubular member of the expansile device isprovided with a third lumen (not shown) extending from the proximal tothe distal extremity and. A mixing chamber contiguous with and createdby the distal confluence of the second and third lumens and is carriedby the distal extremity of the second flexible elongate tubular member.Proximal adaption for sealant introduction and a handle assembly can beutilized as hereinbefore discussed. Operation and use is as hereinbeforedescribed.

Another embodiment of an expansile device incorporating the presentinvention is shown in FIGS. 34-36. The expansile device 701 containselements similar to those present in the device 301. Thus all partspresent in the device 701 that are present in device 301 carry the samenumbers. The device 701 differs from the device 301 in that the closureassembly 307 of the device 701 carries an expansile member 309constructed of an additional segment 702 of nitinol tubing havingproximal and distal ends 703 and 704 which has been adhesively bonded orannealed to the distal extremity 304 of the flexible elongate tubularmember 302. The additional nitinol segment 702 is of appropriatedimensions, having inner and outer diameters approximating those of theflexible elongate tubular member 302 and having a length ranging from0.020-0.060". The segment 702 is provided with a plurality ofcircumferentially spaced apart longitudinally extending slits 706 of asuitable number, preferably eight. The slits 706 form arms or arcuatesegments 707 which when the expansile assembly 307 is in a contractedposition lie in a generally cylindrical configuration 708 which is inalignment with the longitudinal axis of the flexible elongate tubularmember 302 and in an expanded position 709 extend radially from thelongitudinal axis as hereinafter described. The distal end 704 of theadditional segment 702 preferably carries a short hypotube segment 711to which it is appropriately bonded.

The distal end 319 of the push-pull wire 317 of device 701 is coupled orsecured to the distal end 704 of the additional segment 702 by beingsoldered or adhesively bonded to the hypotube segment 711.Alternatively, the distal end 319 of the push-pull wire 317 may extendslightly distal of the distal extremity 304 of the flexible elongatetubular member 302 in which case it carries a small flange 712, thediameter of which approximates the outer diameter of the additionalsegment 702 and the hypotube segment 711, and the flange 712 is securedto the tip of the distal end 704 of the additional segment 702 by beingbonded to the hypotube 711 as hereinbefore described.

The rim 332 of the membrane 311 is affixed exteriorly to the proximalend 703 of the nitinol segment 702, proximal of the slits 706 therein.In lieu of having a closed end as in the device 301, the membrane 311 ofdevice 701 has an open distal end which is circumferentially affixedexteriorly to the distal end 704 of the nitinol segment 702 distal ofthe slits 706 therein.

The proximal extremity 303 of the flexible elongate tubular member 302carries deployment means 308 for controlling movement of the expansilemember 309 between contracted, or cylindrical configurations 708, and aplurality of predetermined expanded configurations 709 of varying sizes,one of which is shown in FIG. 36.

The deployment means 308 includes a handle housing 751 having proximaland distal ends 752 and 753 and having a lumen 754 which is circular incross section and extends from the proximal 752 to the distal end 753 ofthe housing 751. The lumen 754 in the housing 751 is sized so as toaccommodate the push-pull wire 317 which is disposed therein ashereinafter described. The housing 751 is molded of a suitable materialsuch as Polycarb™ and carries a display window 756 for displaying thesize of a predetermined expanded configuration as hereinafter described.

The distal end 753 of the housing 751 carries a slot 757 which is formedby a circumferential enlargement of the lumen 754. The slot 757 hasconcentric proximal and distal portions 758 and 759, the distal portion759 having a diameter which is smaller than the diameter of the proximalportion 758 and slightly larger than the outer diameter of the flexibleelongate tubular member 302 thereby providing the distal end 753 of thehousing 751 with a circumferential, inwardly extending rim or collar 761which is rotatingly coupled to the proximal extremity 303 of theflexible elongate tubular member 302 as hereinafter described.

The portion of the lumen 754 in the proximal end 752 of the housing 751is threaded to engage the proximal end 318 of the push-pull wire 317 ashereinafter described. Alternatively, the proximal end 752 of thehousing 751 can carry a threaded insert 762 made of a suitable material,preferably stainless steel, and having a lumen extending therethroughand aligned with the lumen 754 of the housing 751. The insert 762 may bebonded to the housing 751 by using an appropriate adhesive or befrictionally retained therein.

As shown in FIG. 34, a fitting 766, preferably made of stainless steel,is adhesively, coaxially mounted over and extends proximally beyond theproximal extremity 303 of the flexible elongate tubular member 302. Thefitting 766 carries a lumen 767 aligned with the lumen 306 of theflexible elongate tubular member 302 and is provided with a flangedproximal end 767 which is retained within the slot 757 of the housing751 and seats against the collar 761 therein so that the housing 751 isrotatingly coupled to the flexible elongate tubular member 302 ashereinafter described. The portion of the fitting 766 extendingproximally, beyond the proximal extremity 303 of the flexible elongatetubular member 302, is provided with an inwardly extending pin or key769 so as to be capable of slidingly engaging the push-pull wire 317 ashereinafter described.

The proximal end 318 of the push-pull wire 317 in the device 701 isprovided with threads which engage the threaded portion of the lumen 754in the proximal end 752 of the housing 751. Distal to the threads, thepush-pull wire 317 is provided with a longitudinal groove or channel 771which engages or mates with the key 769 of the fitting 766, ashereinbefore described, so that when the housing 751 is rotated on thepush-pull wire 317 and the fitting 766 carried by the flexible elongatetubular member 302, the push-pull wire 317 and the expansile member 309do not rotate. The portion of the proximal end 318 of the push-pull wire317 distal to the threads and proximal to the fitting 766 carriesnumbers representing the sizes of the various predetermined expandedconfigurations and which are displayed through the display window 756 inthe handle housing 751. It should be appreciated that the proximal end318 of the push-pull wire 317 can be constructed so as to thicker thanthe more distal sections with the wire 317 being tapered distal to thekey 769 of the of the fitting 766 as shown in FIG. 34. The proximal end318 of the push-pull wire 317 is, preferably, also provided with a capor flange 772 constructed of a suitable plastic or metal material forpreventing distal travel of the wire 317 into the housing 751.

Operation and use of the device 701 is similar to that described for theexpansile device 301 except for use of the deployment means in device701. Before the expansile member 309 is deployed to a predeterminedexpanded position 709, the housing 751 has been rotated on the push-pullwire 317 to its distal-most position and the expansile member 309 isthus in its cylindrical configuration 708. When it is desired to movethe expansile assembly 307 to a predetermined expanded configuration709, the proximal end 318 of the push-pull wire 317 is held with onehand while the handle housing 751 is rotated clockwise on the push-pullwire 317 using the operator's other hand. Clockwise rotation of thehousing 751 on the push-pull wire 317 causes pulling on the wire 317 toapply compressive forces to the nitinol additional segment 702 to causeoutward bowing or folding of the arms 707 at their mid-points so thatthe arms 707 extend radially from the longitudinal axis of the flexibleelongate tubular member 302. The membrane 311 is carried along with andexpanded by the arms 707 so that, as hereinbefore described, it isdisposed on both sides of the radially expanded arms 707. The expansilemember 309 may be deployed to a predetermined configuration with aspecific size by observing the size markers or numbers on the wire 317in the display window 756. The larger the desired size of expansion, themore the operator rotates the housing 751 clockwise on the push-pullwire 317 while observing the display window 756.

After occlusion of a puncture, the expansile assembly 307 is de-deployedby reversing the rotation of the housing 751 on the wire 317. Thisreleases the compressive forces on the nitinol additional segment 702which seeks its memorized cylindrical configuration 708 by effecting aninward collapsing of the radially extending arms 707. Thereafter, theclosure device 701 can be retracted in a manner similar to thathereinbefore described with respect to other embodiments. It should alsobe appreciated that the additional nitinol segment can be annealed sothat the memorized configuration is, alternatively, the expandedconfiguration. In this case the contracted, cylindrical configuration isobtained with longitudinal stretching forces being applied to thesegment by the housing and the wire.

It is apparent from the foregoing that there has been provided anexpansile or closure device and method for percutaneous access andocclusion of punctures which medical procedures have required beingplaced in the human body. By varying the free shape or configuration ofthe super elastic alloy expansile member and the size and material ofthe membrane, the predetermined configuration and rigidity of theexpansile assembly is varied so that it becomes possible to occludepuncture sites and natural tracts of various sizes and in variouslocations in the body such as laparoscopic puncture sites,pleural-cutaneous fistulas, including chest-tube puncture sites,intestinal-cutaneous fistulas, fistulas between the intestines, biliarytract of the stomach and the like. The expansile assembly establishesthe distal boundary for the puncture so that it enables accurateplacement of and prevents inadvertent intravascular injection andembolization of the biological sealant. The expansile device of thepresent invention makes possible the use of biological sealants in whichfor example fibrin glue is utilized and forms a clot which has greaterstrength than a natural clot formed by the body. In addition it makes itpossible to the bypass the natural coagulation system of the human bodyeven though anticoagulants have been administered to the patient duringthe prior medical procedure or procedures. Although fibrin glue has beendiscussed as the principal biological sealant, other sealants may beutilized such as collagen, Avitene™ slurries, Gel Foam™, cellulose,fibrin and thrombin, collagen and thrombin mixtures, all of which arenon-adherent to the expansile device. Individual components ofmulti-component sealants may be separately introduced into the differentannular spaces of the expansile device comprising three flexibleelongate tubular members. By utilizing an annular distal mixing chamber,component-to-component fluid contact is maximized. A maximized area ofcontact affords optimal mixing and setting of the sealant at just thesite where it is needed. Furthermore, circumferential introduction ofmixed biological sealant into the puncture provides better distribution.In addition, it should be appreciated that other means of sealantintroduction to the flexible elongate tubular member are available. Forexample, a multi-component sealant such as fibrin glue may,alternatively, be mixed prior to introduction into the flexible elongatetubular member.

The shape of the expansile mechanism utilized in the expansile device ofthe present invention that abuts the inner surface of the wall throughwhich the puncture extends enlists the normal pressure of the arterialblood flow to help retain the expansile assembly in contact with thewall. The expansile assembly is small in size and even when beingdeployed into the blood vessel permits substantially unobstructed bloodflow through the vessel to continue during the expansile procedure thusavoiding ischemic and thrombotic complications associated with stasis ofblood. The small size similarly prevents the expansile assembly fromdamaging or impinging on the opposite wall of the blood vessel duringdeployment or de-deployment of the device.

Since the expansile device and method of the present invention does notrequire long term intravascular deployment of a foreign body such ascollagen, intra-arterial anchors or sutures, nor does it utilize balloontechnology with the attendant risks of balloon rupture or tearing, thereis a greatly reduced risk of life and limb threatening infections andthe introduction of particulates or air emboli into the bloodstream.

The catheter retention and tension applicator of the present inventionprovide a constant force of proximal tension on the deployed device. Aninherent safety feature is the constant force of tension provided over arange of motion as hereinbefore discussed. In other situations, it isdesirable that the tension vary over a range of motion. An embodiment ofthe tensioning device accomplishes this while maintaining inherentsafety features as hereinbefore described. As this obviates the need formanual pressure and clamping devices traditionally used, it freesmedical personnel to attend to other duties.

Since the occlusions which are formed in punctures utilizing theexpansile device and method of the present invention can be accomplishedquickly, this facilitates early ambulation of the patient and helps toavoid traditional complications such as arterio-venous fistulas,pseudo-aneurysms, thrombosis and embolism. Since the device is typicallydisposed of after one use, the danger of transmitting diseases to theblood stream of the patient is greatly reduced. Medical costs to thepatient and to society are also thereby reduced.

Although the expansile device and method have been described principallyin use with the human body it should be appreciated that the expansiledevice and method also can be utilized with animals in a similar manner.

In addition, it should be appreciated that the expansile device can beused within other natural tracts in the body in order to provide forother therapeutic or prophylactic modalities.

It is apparent from the foregoing that there has been provided aexpansile device and method for percutaneous access and occlusion ofpuncture sites in the human body that have distinct advantages overthose heretofore provided.

Percutaneous methods are widespread techniques that offer less invasive,safer and more cost-effective diagnostic and therapeutic access toorgans of the human body. In order to fully realize the advantages ofpercutaneous access however, morbidity associated with access sites mustbe anticipated and prevented wherever possible. Indeed, advancedtherapeutic interventions have led to a greater range of access sitecomplications. A patient who suffers such complications must oftenundergo a more invasive procedure in order to prevent devastating injuryto life or limb. Such procedures incur additional risks and costs.Effective percutaneous occlusion of a percutaneous vascular access sitethat proves to be otherwise difficult to manage is a major achievement.Without such treatment many of the advantages of percutaneous diagnosticand therapeutic procedures are lost. Satisfactory solutions haveheretofore been absent in the prior art. The device and method of thepresent invention obviate many of the morbid side effects associatedwith puncture sites hereinbefore described.

What is claimed is:
 1. A device for use by a human hand for expansionwithin a blood vessel having a wall defining a lumen in the bodycomprising an elongate tubular member having proximal and distalextremities and having a longitudinal axis, an expansile member carriedby the distal extremity of the elongate tubular member and movablebetween contracted and expanded positions, a deformable membranecovering at least a portion of the expansile member, a handle mechanismadapted to be grasped by the human hand and a push-pull elementextending through the elongate tubular member and having a distalextremity coupled to the expansile member and a proximal extremitycoupled to said handle mechanism, said handle mechanism being movableindependently relative to said push-pull element so that operation ofsaid handle mechanism causes longitudinal movement of said push-pullelement to cause movement of said expansile member between thecontracted and expanded positions.
 2. A device as in claim 1 wherein theexpansile member has proximal and distal extremities, the distalextremity of the push-pull element being secured to the distal extremityof said expansile member.
 3. A device as in claim 2 wherein saidexpansile member in a contracted position includes a plurality ofcircumferentially spaced apart longitudinal slits forming arms whichwhen the expansile member is in an expanded position extend radiallyfrom the longitudinal axis of the elongate tubular member.
 4. A deviceas in claim 3 wherein said expansile member has at least eightcircumferentially spaced apart longitudinal slits.
 5. A device as inclaim 3 wherein said expansile member has a plurality of predeterminedexpanded configurations.
 6. A device as in claim 5 wherein saidplurality of predetermined configurations are of varying sizes.
 7. Adevice for expansion within a blood vessel having a wall defining alumen in the body comprising a first elongate tubular member havingproximal and distal extremities and having a longitudinal axis, anexpansile member carried by the distal extremity of the first elongatetubular member and movable between contracted and expanded positions,said expansile member having a predetermined configuration in theexpanded position, a deformable membrane covering the expansile member,said deformable membrane being sized so as to be capable of overlyingand underlying the expansile member in the expanded position anddeployment means carried by the proximal extremity of the first elongatetubular member and adapted to be operated by the human hand forcontrolling movement of the expansile member between the contracted andexpanded positions, said deployment means including a push-pull wirehaving proximal and distal extremities, said push-pull wire extendingthrough the first elongate tubular member and being coupled to theexpansile member, the expansile member having proximal and distalextremities, the distal extremity of said push-pull wire being securedto the distal extremity of said expansile member, said expansile memberincluding a plurality of circumferentially spaced apart slits formingarms which when the expansile assembly is in a contracted position liein a generally cylindrical configuration which is in alignment with thelongitudinal axis of the first elongate tubular member and in anexpanded position extend radially from the longitudinal axis, saidexpansile member having a plurality of predetermined expandedconfigurations, said plurality of predetermined configurations being ofvarying sizes and a display carried by the deployment means fordisplaying the size of a predetermined expanded configuration.
 8. Adevice as in claim 6 wherein said expansile member is comprisedessentially of a superelastic material.
 9. A device as in claim 6wherein said expansile member is comprised of Nitinol tubing.
 10. Adevice as in claim 1 further including means for applying tension tomaintain engagement of said expansile member in the expanded positionwith the wall in the lumen of the blood vessel.
 11. A device as in claim10 wherein said tension means includes a tensioning member having a baseportion, an arm movable between open and closed arm positions withrespect to said base portion, a spring member connecting said arm tosaid base portion, said spring member biasing said arm into the open armposition, at least two cooperative grasping portions carried by said armand movable between disengaging and engaging positions for grasping saidelongate tubular member, said grasping portions being yieldably biasedtoward said engaging position.
 12. A device as in claim 11 wherein saidspring is capable of exerting a force ranging from 0.5-4 ounces oftension, said force varying with movement of said arm between open andclosed arm positions.
 13. A device as in claim 11 wherein said spring,arm and base are constructed of one piece.
 14. A device as in claim 11wherein said tensioning member is constructed of one piece.
 15. A deviceas in claim 11 further including a first slot in the base and a secondslot in the arm which is aligned with the first slot when the arm is inthe closed position, said elongate tubular member being disposed in saidfirst and second slots when grasped by said grasping portions.
 16. Adevice for expansion within a blood vessel having a wall defining alumen in the body comprising an elongate tubular member having proximaland distal extremities, an expansile member carried by the distalextremity of the elongate tubular member and movable between contractedand expanded configurations, a deformable membrane covering at least aportion of the expansile member, deployment means carried by theproximal extremity of the elongate tubular member for controllingmovement of the expansile member between the contracted and expandedconfigurations and a display carried by the deployment means fordisplaying the size of said expanded configuration.
 17. A device forexpansion within a blood vessel having a wall defining a lumen in thebody comprising an elongate tubular member having proximal and distalextremities, an expansile member carried by the distal extremity of theelongate tubular member and movable between contracted and expandedpositions, a deformable membrane covering at least a portion of theexpansile member, deployment means carried by the proximal extremity ofthe elongate tubular member for controlling movement of the expansilemember between the contracted and expanded positions and a handleadapted to be held by the human hand and coupled to said deploymentmeans, said handle being rotatable independently of said deploymentmeans during movement of the expansile member between contracted andexpanded positions.
 18. A device for expansion within a blood vesselhaving a wall defining a lumen in the body comprising an elongatetubular member having proximal and distal extremities and a longitudinalaxis, an expansile member carried by the distal extremity of theelongate tubular member and movable between contracted and expandedpositions, a deformable membrane covering at least a portion of theexpansile member, deployment means carried by the proximal extremity ofthe elongate tubular member for controlling movement of the expansilemember between the contracted and expanded positions, a handle adaptedto be held by the human hand and coupled to said deployment means, saidhandle and said deployment means being movable independently of oneanother.